1. ©2007 Wortham Laboratories, Inc.
Training
Coagulation Training
Presentation v1.1 –
©2007 Wortham Laboratories, Inc.

2. Wortham Training
This presentation is intended to inform our sales network and professional medical practitioners about the next generation of coagulation products. This presentation is made available with the following important conditions inherent to the delivery of product information to the medical community and our sales network:
While the information prepared herein is presented in good faith, changes may occur which affect the intended result of this presentation. Please understand that literature and training regarding the proper utilization of Wortham products may be updated at any time. Material changes in product information will be made available as changes are made.
This presentation was prepared in June Each WLI Presentation is dated.
The use of any medical product requires specific instruction which may exceed the scope of this presentation. Please consult Wortham Laboratories product inserts, your distributor and/or our support desk with any product questions. We are devoted to your satisfaction and success. While this presentation represents Wortham products as suitable for a particular purpose, the presentation alone cannot act as a sole source of information for introducing this product into your laboratory or other setting. We will provide a full complement of supporting tools and documentation to assist you. The contents of this presentation are Copyright ©2007 Wortham Laboratories. This presentation contains internationally recognized trademark of Wortham Laboratories, Incorporated. Other trademarks referenced herein are the property of their specific owners, and are incorporated throughout for the exclusive purpose of information, education and training.
THIS PRESENTATION IS FORMATTED FOR NARRATIVE HOSTING, and cannot serve as a sole product insert or instructional reference document.
WELCOME TO WORTHAM LABORATORIES – TOMORROW’S TECHNOLOGY TODAY

3. Indications for Use

4. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Stasis 1 Coagulation Control (Normal)
Indications For Use:
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.

5. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Stasis 2 Coagulation Control (Abnormal)
Indications For Use:
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.

6. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Stasis 3 Coagulation Control (Abnormal)
Indications For Use:
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.

7. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Serathan-A PT Reagent
Indications For Use:
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.

8. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Serathan-B PT Reagent
Indications For Use:
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.

9. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Intrin-SI APTT Reagent
Indications For Use:
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.

10. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Intrin-EA APTT Reagent
Indications For Use:
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.

11. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Control Plasma Normal
Indications For Use:
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.

12. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Control Plasma Low
Indications For Use:
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.

13. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Heparin Control Plasma Level 1
Indications For Use:
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.

14. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Heparin Control Plasma Level 2
Indications For Use:
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.

15. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Assay Set
Indications For Use:
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control ( mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intended for use in the quantitative determination of fibrinogen in plasma samples.

16. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Buffer
Indications For Use:
Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.

17. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Thrombin Reagent
Indications For Use:
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.

18. Indications for Use 510(k) Number (if known): K060968
Device Name: Wortham Laboratories Calcium Chloride Solution 0.02 M
Indications For Use:
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.

19. Product Inserts: Stasis I

20. Product Inserts: Stasis 1 Coagulation Control Plasma Level 1 (Normal)
Intended Use Review
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.

21. Product Inserts: Stasis 1 Coagulation Control Plasma Level 1 (Normal)
Summary and Principle
The use of plasma controls is essential for assuring quality in coagulation testing. Normal and abnormal controls should be run with each group of assays, with every 40 samples, reagent changes, instrument modification, and with a change in personnel. Stasis 1 and at least one abnormal control such as Stasis 2 or Stasis 3, are an integral part of a complete quality assurance program.

22. Product Inserts: Stasis 1 Coagulation Control Plasma Level 1 (Normal)
Expected Values
When Stasis 1 was evaluated on 60 samples on the BBL Fibrometer, the following results were obtained:
Serathan-B (ISI=1.58)
Serathan-A (ISI=1.20)
Mean
±2SD PT
11.7 sec
sec.
12.6 sec.
sec.
Intrin - SI
Intrin - EA
APTT
29.5 sec
sec
29.0 sec
sec
Fibrinogen - Normal
Fibrinogen
301 mg/dl
mg/dl

23. Product Inserts: Stasis 1 Coagulation Control Plasma Level 1 (Normal)
Regarding Expected Values
These values should only be used as a guideline. Each laboratory should establish a Normal Reference Range (NRR) using instrumentation, blood collection methods, and testing techniques used in that laboratory. The NRR should be reestablished or at least verified when changing lot numbers of the same control. A new NRR should be established with any change in reagents, instrumentation, blood collection techniques or anticoagulant.

24. Product Inserts: Stasis 1 Coagulation Control Plasma Level 1 (Normal)
Performance Characteristics
Stasis 1 Control is formulated to have PT, APTT, and Fibrinogen values in the normal range. The reproducibility of three lots of the control, a run-run (n=180) singlicate assays, produced a coefficient of variations of < 1% for the PT, < 1% for the APTT, and < 1% for Fibrinogen assays on the BBL Fibrometer. Actual values recorded depend on the instrument and reagent used.

25. Product Inserts: Stasis II

26. Product Inserts: Stasis 2 Coagulation Control Plasma Level 2 (Abnormal)
Intended Use
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.

27. Product Inserts: Stasis 2 Coagulation Control Plasma Level 2 (Abnormal)
Summary and Principle
The use of plasma controls is essential for assuring quality in coagulation testing. Normal and abnormal controls should be run with each group of assays, with every 40 samples, reagent changes, instrument modification, and with a change in personnel. Stasis 2 and a normal control, such as Stasis 1, are an integral part of a complete quality assurance program.

28. Product Inserts: Stasis 2 Coagulation Control Plasma Level 2 (Abnormal)
Expected Values
When Stasis 2 was evaluated on 60 samples on the BBL Fibrometer, the following results were obtained:
Serathan-B (ISI=1.58)
Serathan-A (ISI=1.20)
Mean
±2SD PT
21.2 sec.
sec.
36.4 sec.
sec.
Intrin - SI
Intrin - EA
APTT
55.8 sec.
sec.
46.5 sec.
sec.

29. Performance Characteristics
Product Inserts: Stasis 2 Coagulation Control Plasma Level 2 (Abnormal)
Performance Characteristics
Stasis 2 Control is formulated to have PT, APTT values in the moderate abnormal range. The reproducibility of three lots of the control, a run-run (n=180) singlicate assays, produced a coefficient of variations of < 1% for the PT, < 1.5% for the APTT assays on the BBL Fibrometer. Actual values recorded depend on the instrument and reagent used.

30. Product Inserts: Stasis III

31. Product Inserts: Stasis 3 Coagulation Control Plasma Level 3 (Abnormal)
Intended Use
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.

32. Product Inserts: Stasis 3 Coagulation Control Plasma Level 3 (Abnormal)
Summary and Principle
The use of plasma controls is essential for assuring quality in coagulation testing. Normal and abnormal controls should be run with each group of assays, with every 40 samples, reagent changes, instrument modification, and with a change in personnel. Stasis 3 and a normal control, such as Stasis 1, are an integral part of a complete quality assurance program.

33. Product Inserts: Stasis 3 Coagulation Control Plasma Level 3 (Abnormal)
Expected Values
When Stasis 3 was evaluated on 60 samples on the BBL Fibrometer, the following results were obtained:
Serathan-B (ISI=1.58)
Serathan-A (ISI=1.20)
Mean
±2SD PT
32.5 sec.
sec.
61.5 sec.
sec.
Intrin - SI
Intrin - EA
APTT
70.5 sec.
sec.
64.8 sec.
sec.

34. Performance Characteristics
Product Inserts: Stasis 3 Coagulation Control Plasma Level 3 (Abnormal)
Performance Characteristics
Stasis 3 Control is formulated to have PT, APTT values in the strongly abnormal range. The reproducibility of three lots of the control, a run-run (n=180) singlicate assays, produced a coefficient of variations of < 1% for the PT, < 1.6% for the APTT assays on the BBL Fibrometer. Actual values recorded depend on the instrument and reagent used.

35. Product Inserts: Serathan A

36. Product Inserts: Serathan-A Thromboplastin Reagent
Intended Use
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.

37. Product Inserts: Serathan-A Thromboplastin Reagent
Summary and Principle
The PT is used as a screen and quantitative test for coagulation factors in the extrinsic and common pathways. Patients with acquired or congenital disorders that reduce the activities of Factor I (fibrinogen), II (Prothrombin), V (Proaccelerin), VII (Stable) and X (Stuart) will be prolonged in this test. The PT is widely used to monitor oral anticoagulation therapy. 1,2 Oral anticoagulants reduce the activity of Vitamin K dependent clotting factors (II,VII,IX,X, Protein C, and Protein S), and the PT is prolonged as a result. The one step PT measures the clotting time of plasma after adding a source thrombplastin and calcium. The recalcification of plasma with thromboplastin generates activated FXa. FXa in turn activates Prothombin to thrombin, which converts fibrinogen to an insoluble fibrin clot.

38. Product Inserts: Serathan-A Thromboplastin Reagent
Expected Values
In an outside laboratory, when Serathan-A was evaluated on a normal population, the following results were obtained:
Instrument
PT Mean (sec)
Range (± 2SD) N
ACL Advance
12.1
11.9 – 12.3 60
These values are intended as a guideline only. Each laboratory should establish a Normal Reference Range (NRR) using instrumentation, blood collection methods, and testing techniques used in that laboratory. The NRR should be reestablished or at least verified when changing lot numbers of the same reagent. A new NRR should be established with any change in reagents, instrumentation, blood collection techniques, or anticoagulant.
The clotting time of abnormal plasmas will depend on the ISI of the reagent lot in use.

39. Product Inserts: Serathan-A Thromboplastin Reagent
Performance Characteristics / Precisions
Precisions: Precision of Prothrombin Time results is dependent on many factors, such as the instrument technique and the reagent in use. Serathan-A was assayed by testing the reagent against three lots each of a normal and abnormal control plasma, in singlicate assays, on the BBL Fibrometer. A summary of the results follow:
Level 1
Level 2
Level 3 n
run(sec)
% CV
within-run 60
12.66
0.89%
36.45
1.09%
61.60
1.25%
run-run
12.67
0.88%
36.47
1.08%
61.13
1.28%

40. Product Inserts: Serathan-A Thromboplastin Reagent
Performance Characteristics / Sensitivity
Sensitivity: Serathan-A detects deficiencies in the extrinsic pathway as determined by the Prothrombin Time test. Factor sensitivity testing was performed by diluting pool normal plasma, with factor deficient plasmas such that the final factor concentration ranged from %. Pt testing of those samples was performed on the BBL Fibrometer instrument:
Prothrombin Time (Mean sec) n = 20
% Factor
Factor II
Factor V
Factor VII
Factor X
100
11.79
11.99
11.90 50
11.80
13.41
12.79
13.11 40
12.02
14.20
12.98
13.60 30
12.38
15.20
13.82
14.52 20
12.99
16.29
14.11
15.21 10
14.31
18.66
15.51
17.52

41. Product Inserts: Serathan-A Thromboplastin Reagent
Reportable Range/Linearity
The linearity of Serathan-A to warfarin (n=40), measured on the BBL Fibrometer, was mg/dl.
Each laboratory should establish their own linearity, using instrumentation, blood collection methods, and testing techniques used in the laboratory.

42. Product Inserts: Serathan-A Thromboplastin Reagent
Determination of INR
An undesirable consequence of oral anticoagulant therapy may be a tendency to bleed unnecessarily. To maximize the desired therapeutic effects and minimize bleeding, the World Health Organization (WHO) has recommended a procedure to standardize testing and treatments. This procedure is based on the International Normalized Ratio (INR).

43. Product Inserts: Serathan-A Thromboplastin Reagent
Determination of INR
The INR is calculated using the ratio of the patient PT to the mean of the NRR (mean NRR) according to the following mathematical relationship:

44. Product Inserts: Serathan-A Thromboplastin Reagent
Determination of INR
For example only: With an ISI of 1.20 and a mean normal of 12.2 seconds, the INR for a PT of 28.2 seconds is calculated as follows:

45. Product Inserts: Serathan-A Thromboplastin Reagent
International Sensitivity Index (ISI)
The International Sensitivity Index (ISI) is a measure of the thromboplastin/instrument sensitivity to coagulation factors. ISI values are assigned by comparison to a primary reference material. By preparing a range of warfarin plasma samples, Serathan-A reagent is measured against a European Reference Material (ERM), using a thromboplastin standard. High sensitivity reagents have low ISI values. According to WHO recommendations, INR values above 5.5 place the patient at unnecessarily risk for bleeding complications. It is generally advised that patients on stabilized oral anticoagulant therapy should be maintained at an INR of 2.0 – 3.5, depending on the clinical indication. The lot specific ISI value for Serathan-A can be found on the box label.

46. Product Inserts: Serathan-A Thromboplastin Reagent
Correlation Studies
Correlation studies were performed against another thromboplastin reagent by performing PT testing on 120 adult normal and coumadin patient samples, in singlicate assays. Testing was performed on the BBL Fibrometer instrument.
Reference PT Clotting Time (sec)
R = 0.999
y = x+ 0.62

47. Product Inserts: Serathan-A Thromboplastin Reagent
Correlation Studies
Reference PT Clotting Time (sec)
R = 0.999
y = x

48. Product Inserts: Serathan B

49. Product Inserts: Serathan-B Thromboplastin Reagent
Intended Use
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.

50. Product Inserts: Serathan-B Thromboplastin Reagent
Summary and Principle
The PT is used as a screen and quantitative test for coagulation factors in the extrinsic and common pathways. Patients with acquired or congenital disorders that reduce the activities of Factor I (fibrinogen), II (Prothrombin), V (Proaccelerin), VII (Stable) and X (Stuart) will be prolonged in this test. The PT is widely used to monitor oral anticoagulation therapy. 1,2 Oral anticoagulants reduce the activity of Vitamin K dependent clotting factors (II,VII,IX,X, Protein C, and Protein S), and the PT is prolonged as a result. The one step PT measures the clotting time of plasma after adding a source thrombplastin and calcium. The recalcification of plasma with thromboplastin generates activated FXa. FXa in turn activates Prothombin to thrombin, which converts fibrinogen to an insoluble fibrin clot.

51. Product Inserts: Serathan-B Thromboplastin Reagent
Expected Values
In an outside laboratory, when Serathan-B was evaluated on a normal population, the following results were obtained:
Instrument
PT Mean (sec)
Range (± 2SD) N
ACL Advance
11.5 60
These values are intended as a guideline only. Each laboratory should establish a Normal Reference Range (NRR) using instrumentation, blood collection methods, and testing techniques used in that laboratory. The NRR should be reestablished or at least verified when changing lot numbers of the same reagent. A new NRR should be established with any change in reagents, instrumentation, blood collection techniques, or anticoagulant.
The clotting time of abnormal plasmas will depend on the ISI of the reagent lot in use.

52. Product Inserts: Serathan-B Thromboplastin Reagent
Performance Characteristics / Precisions
Precisions: Precision of Prothrombin Time results is dependent on many factors, such as the instrument technique and the reagent in use. Serathan-B was assayed by testing the reagent against three lots each of a normal and abnormal control plasma, in singlicate assays, on the BBL Fibrometer. A summary of the results follow:
Level 1
Level 2
Level 3 n
run(sec)
% CV
within-run 60
11.57
0.80%
21.17
1.27%
32.51
1.42%
run-run
11.56
0.75%
21.13
1.22%
1.44%

53. Product Inserts: Serathan-B Thromboplastin Reagent
Performance Characteristics / Sensitivity
Sensitivity: Serathan-B detects deficiencies in the extrinsic pathway as determined by the Prothrombin Time test. Factor sensitivity testing was performed by diluting pool normal plasma, with factor deficient plasmas such that the final factor concentration ranged from %. Pt testing of those samples was performed on the BBL Fibrometer instrument:
Prothrombin Time (Mean sec) n = 20
% Factor
Factor II
Factor V
Factor VII
Factor X
100
11. 00
11.49
11.40
11.60 50
11.01
11.89
12.41
13.39 40
13.09
13.82 30
11.79
13.19
13.90
14.91 20
12.30
14.70
14.79
16.32 10
13.71
17.12
16.48
20.02

54. Product Inserts: Serathan-B Thromboplastin Reagent
Reportable Range/Linearity
The linearity of Serathan-B to warfarin (n=40), measured on the BBL Fibrometer, was mg/dl.
Each laboratory should establish their own linearity, using instrumentation, blood collection methods, and testing techniques used in the laboratory.

55. Product Inserts: Serathan-B Thromboplastin Reagent
Determination of INR
An undesirable consequence of oral anticoagulant therapy may be a tendency to bleed unnecessarily. To maximize the desired therapeutic effects and minimize bleeding, the World Health Organization (WHO) has recommended a procedure to standardize testing and treatments. This procedure is based on the International Normalized Ratio (INR).

56. Product Inserts: Serathan-B Thromboplastin Reagent
Determination of INR
The INR is calculated using the ratio of the patient PT to the mean of the NRR (mean NRR) according to the following mathematical relationship:

57. Product Inserts: Serathan-B Thromboplastin Reagent
Determination of INR
For example only: With an ISI of 1.55 and a mean normal of 11.4 seconds, the INR for a PT of 26.9 seconds is calculated as follows:

58. Product Inserts: Serathan-B Thromboplastin Reagent
International Sensitivity Index (ISI)
The International Sensitivity Index (ISI) is a measure of the thromboplastin/instrument sensitivity to coagulation factors. ISI values are assigned by comparison to a primary reference material. By preparing a range of warfarin plasma samples, Serathan-B reagent is measured against a European Reference Material (ERM), using a thromboplastin standard. High sensitivity reagents have low ISI values. According to WHO recommendations, INR values above 5.5 place the patient at unnecessarily risk for bleeding complications. It is generally advised that patients on stabilized oral anticoagulant therapy should be maintained at an INR of 2.0 – 3.5, depending on the clinical indication. The lot specific ISI value for Serathan-B can be found on the box label.

59. Product Inserts: Serathan-B Thromboplastin Reagent
Correlation Studies
Correlation studies were performed against another thromboplastin reagent by performing PT testing on 120 adult normal and coumadin patient samples, in singlicate assays. Testing was performed on the BBL Fibrometer instrument.
Reference PT Clotting Time (sec)
R = 0.996
y = x

60. Product Inserts: Serathan-B Thromboplastin Reagent
Correlation Studies
Reference PT Clotting Time (sec)
R = 0.999
y = x

61. Lupus Sensitivity Study to Serathan and Intrin Reagents Objective: Perform a Lupus sensitivity comparative study of Intrin-SI and Intrin-EA to Pacific Hemostasis’ Kontact and APTT-LS reagents.

62. Lupus Sensitivity Study Materials & Equipment Lupus Plasma Samples Serathan-A Reagent Serathan-B Reagent Pacific Hemostasis DS Reagent Pacific Hemostasis D Reagent Intrin-SI Reagent Intrin-EA Reagent Pacific Hemostasis Kontact Reagent Pacific Hemostasis APTT-LS Reagent 0.02 M CaCl2 Fibrometer 0.1, 0.2 Pipetter 0.1-1ml Volumetric Pipetter

63. Lupus Sensitivity Study
Procedure:
Twenty samples of positive anticoagulant Lupus samples from George King Biological (Lot GK g1) were measured by performing a PT on Wortham Laboratories Serathan-A (ISI=1.20) and Serathan-B (ISI=1.52) and Intrin reagents and comparing them to the predicate device Pacific Hemostasis Thromboplastin-DS (ISI=1.20) and Thromboplastin-D (ISI=1.54). APTT reagents Intrin-SI and Intrin-EA were measured against the Predicate Kontact and APTT-LS, a Kaolin and ellagic acid activator, respectively.

64. Lupus Sensitivity Study: Results
Sample
Serathan-A
Serathan-B
Thrombo-DS
Thrombo-D
Level 1
12.4
11.4
10.6
Level 2
36.0
22.4
35.2
21.7
Level 3
68.3
32.9
66.9
31.2 1
13.8
12.9
11.9 2
13.9
13.4 3
13.5 4 5
12.5 6 7 8 9 10
Mean
13.82
12.42
13.36
12.00 SD
0.040
0.273
0.200
%CV
0.29
0.32
2.04
1.67
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

65. Lupus Sensitivity Study: Results
Sample
Intrin-SI
Kontact
Intrin-EA
APTT-LS
Level 1
28.0
27.4
28.4
27.9
Level 2
40.4
39.4
41.3
Level 3
55.8
51.4
62.6
60.4 1
58.3
61.9
33.5
32.4 2
59.2
57.0
28.9 3
57.5
58.9
30.7 4
52.8
47.9
31.2 5
50.3
38.5
25.9 6
49.7
43.9 7
44.4
35.1 8
57.2
66.9
34.6
33.9 9
46.9
32.3 10
56.5
48.9
32.7
Mean
55.07
51.52
32.56
28.95 SD
3.51
8.65
1.43
2.26
%CV
6.37
16.80
4.39
7.81
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

66. Lupus Sensitivity Study: Conclusions
Although Lupus has little effect on the extrinsic system, clearly, only the PT reagents with a 1.20 ISI detected its anticoagulant effect. The silicone activator in both of the APTT reagents was sensitive to positive Lupus anticoagulant plasma, while the thromboplastin reagent with a ISI and the ellagic acid activator remained unresponsive. The stabilizers in the Wortham Laboratories reagents gave a more consistent reproducible result of the PT reagents Serathan-A and Serathan-B standard deviation to Thromboplastin-DS and Thromboplastin-D SD. Likewise, the stability of Intrin-SI and Intrin-EA produced a and SD, respectively, compared to the predicates Kontacts SD and APTT-LS SD.
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

67. Serathan Reagent Linearity Study Objective: This study was to measure the linearity of Serathan-A and Serathan-B reagents.

68. Serathan Reagent Linearity Study Materials & Equipment Serathan-A (1
Serathan Reagent Linearity Study Materials & Equipment Serathan-A (1.20 ISI) Reagent Serathan-B (1.52 ISI) Reagent Stasis 1 Control Warfarin Fibrometer 1-10 μl Pipetter 0.1, 0.2 Pipetter ml Volumetric Pipetter

69. Serathan Reagent Linearity Study: Procedure
Eighteen samples of warfarin plasma were prepared from 0.2g warfarin/ml H2O, by adding the following volumes to normal plasma:
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV
Each sample was run in singlicate, assayed using standard PT procedures on the BBL Fibrometer.

70. Serathan Reagent Linearity Study: RESULTS
Serathan-A
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

71. Serathan Reagent Linearity Study: RESULTS
Thromboplastin-DS
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

72. Serathan Reagent Linearity Study: RESULTS
Serathan-B
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

73. Serathan Reagent Linearity Study: RESULTS
Thromboplastin-D

74. Product Inserts: Intrin-SI

75. Product Inserts: Intrin-SI Activated PTT Reagent
Intended Use
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.

76. Product Inserts: Intrin-SI Activated PTT Reagent
Summary and Principle
The Activated Partial Thromboplastin Time (APTT) is an established tool as a quantitative test for the intrinsic coagulation factors. It is a simple versatile test which is sensitive to functional deficiencies of factors VIII, IX, XI, XII. The APTT is also used in the monitoring of heparin therapy, where the clotting time is prolonged in proportion to the level of heparin. The APTT is performed by adding reagent containing a plasma activator and phospholipid to the test specimen. The mixture is incubated for 3 minutes at 37°C for optimum activation. Calcium chloride is added and clot formation is timed.

77. Product Inserts: Intrin-SI Activated PTT Reagent
Expected Values
When Intrin-SI was evaluated on 60 normal adult patients on the BBL Fibrometer, the following results were obtained:
PT Mean (sec)
Range (± 2SD) N
Photo-optical
29.5 60
Mechanical
These values should only be used as a guideline. Each laboratory should establish a Normal Reference Range (NRR) using instrumentation, blood collection methods, and testing techniques used in that laboratory. The NRR should be reestablished or at least verified when changing lot numbers of the same control. A new NRR should be established with any change in reagents, instrumentation, blood collection techniques or anticoagulant.

78. Product Inserts: Intrin-SI Activated PTT Reagent
Performance Characteristics / Precision
Precision of the Activated Partial Thromboplastin Time result is dependent on many factors, such as the instrument technique and the reagent in use. Intrin-SI was assayed by testing normal and abnormal plasmas on the BBL Fibrometer. A Summary of the results follows:
Level 1
Level 2
Level 3 n
run(sec)
% CV
within-run 60
29.51
0.29%
55.75
0.74%
70.49
0.75%
run-run

79. Product Inserts: Intrin-SI Activated PTT Reagent
Performance: Heparin Sensitivity
Intrin-SI sensitivity to heparin was measured by comparison testing. The mean of 60 heparin patient samples on the BBL Fibrometer was for Intrin-SI and for the Reference APTT reagent, yielding a 4.90 mean difference. Regression analysis demonstrated a correlation coefficient of
Intrin-SI APTT Clotting Time (sec)
R = 0.995
y = x
Each laboratory should establish its own heparin sensitivity curve using the same heparin source used for therapy in that institution. Variations can result from different brands of heparin, tissue origin, and salt forms.

80. Product Inserts: Intrin-SI Activated PTT Reagent
Performance Characteristics / Sensitivity
Intrin-SI detects deficiencies in the intrinsic pathway as determined by the APTT. Factor sensitivity testing was performed by diluting pool normal plasma, with factor deficient plasmas such that the final factor concentration range was from %. Testing of the sample was performed on the BBL Fibrometer instrument:
Activated Partial Thromboplastin Time (Mean sec) n = 20
% Factor
Factor VIII
Factor IX
Factor XI
Factor XII
100
28.52
29.59
29.17
28.56 50
34.77
32.78
30.35 40
38.02
35.80
34.23 30
42.31
42.61
39.57
37.83 20
49.91
50.22
46.00
41.59 10
57.21
56.14
53.68
48.83

81. Product Inserts: Intrin-SI Activated PTT Reagent
Reportable Range/Linearity
A linearity study, assayed on the BBl Fibrometer, of Intrin-SI to measure heparin in 18 plasma samples of 0-5 U/ml, yielded a linearity range of seconds.
Each laboratory should establish their own linearity, using instrumentation, blood collection methods, and testing techniques used in the laboratory.

82. Product Inserts: Intrin-SI Activated PTT Reagent
Correlation Studies
Correlation studies were performed against another thromboplastin reagent by performing APTT testing on 120 adult normal and heparinized patient samples, and 10 lupus anticoagulant plasma samples in singlicate assay, on the BBL Fibrometer.
Reference APPT Clotting Time (sec)
R = 0.998
y = x+ 0.15

83. Product Inserts: Intrin-SI Activated PTT Reagent
Correlation Studies
Reference APPT Clotting Time (sec)
R = 0.844
y = x- 4.76

84. Product Inserts: Intrin-EA

85. Product Inserts: Intrin-EA Activated PTT Reagent
Intended Use
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.

86. Product Inserts: Intrin-EA Activated PTT Reagent
Summary and Principle
The Activated Partial Thromboplastin Time (APTT) is an established tool as a quantitative test for the intrinsic coagulation factors. It is a simple versatile test which is sensitive to functional deficiencies of factors VIII, IX, XI, XII. The APTT is also used in the monitoring of heparin therapy, where the clotting time is prolonged in proportion to the level of heparin. The APTT is performed by adding reagent containing a plasma activator and phospholipid to the test specimen. The mixture is incubated for 3 minutes at 37°C for optimum activation. Calcium chloride is added and clot formation is timed.

87. Product Inserts: Intrin-EA Activated PTT Reagent
Expected Values
When Intrin-EA was evaluated on 60 normal adult patients on the BBL Fibrometer, the following results were obtained:
PT Mean (sec)
Range (± 2SD) N
Photo-optical
29.0
28.7 – 29.3 60
Mechanical
28.5 – 29.5
These values should only be used as a guideline. Each laboratory should establish a Normal Reference Range (NRR) using instrumentation, blood collection methods, and testing techniques used in that laboratory. The NRR should be reestablished or at least verified when changing lot numbers of the same control. A new NRR should be established with any change in reagents, instrumentation, blood collection techniques or anticoagulant.

88. Product Inserts: Intrin-EA Activated PTT Reagent
Performance Characteristics / Precision
Precision of the Activated Partial Thromboplastin Time result is dependent on many factors, such as the instrument technique and the reagent in use. Intrin-EA was assayed by testing the reagent against normal and abnormal control plasmas, in singlicate assays, on the BBL Fibrometer. A Summary of the results follows:
Level 1
Level 2
Level 3 n
run(sec)
% CV
within-run 60
29.01
0.51%
48.03
0.41%
67.74
0.73%
run-run
29.03
0.60%
47.52
0.44%
0.71%

89. Product Inserts: Intrin-EA Activated PTT Reagent
Performance: Heparin Sensitivity
Intrin-EA sensitivity to heparin was measured by comparison testing. The mean of 60 heparin patient samples on the BBL Fibrometer was for Intrin-EA and for the Reference APTT reagent, yielding a 3.72 mean difference. Regression analysis demonstrated a correlation coefficient of
Intrin-EA APTT Clotting Time (sec)
R = 0.996
y = x
Each laboratory should establish its own heparin sensitivity curve using the same heparin source used for therapy in that institution. Variations can result from different brands of heparin, tissue origin, and salt forms.

90. Product Inserts: Intrin-EA Activated PTT Reagent
Performance Characteristics / Sensitivity
Intrin-EA detects deficiencies in the intrinsic pathway as determined by the APTT. Factor sensitivity testing was performed by diluting pool normal plasma, with factor deficient plasmas such that the final factor concentration range was from %. Testing of the sample was performed on the BBL Fibrometer instrument:
Activated Partial Thromboplastin Time (Mean sec) n = 20
% Factor
Factor VIII
Factor IX
Factor XI
Factor XII
100
29.36
28.54
29.47
26.82 50
33.86
32.38
34.74
29.89 40
35.08
34.03
36.26
31.14 30
37.33
36.34
38.61
32.23 20
40.47
38.64
41.35
33.33 10
45.10
40.89
46.84
35.04

91. Product Inserts: Intrin-EA Activated PTT Reagent
Reportable Range/Linearity
A linearity study, assayed on the BBL Fibrometer, of Intrin-EA to measure heparin in 18 plasma samples of 0-5 U/ml, yielded a linearity range of 29.0 – 70.7 seconds.
Each laboratory should establish their own linearity, using instrumentation, blood collection methods, and testing techniques used in the laboratory.

92. Product Inserts: Intrin-EA Activated PTT Reagent
Correlation Studies
Correlation studies were performed against another thromboplastin reagent by performing APTT testing on 120 adult normal and heparinized patient samples, and 10 lupus anticoagulant plasma samples in singlicate assay, on the BBL Fibrometer.
Reference APPT-LS Clotting Time (sec)
R = 0.996
y = x

93. Product Inserts: Intrin-EA Activated PTT Reagent
Correlation Studies
Reference APPT-LS Clotting Time (sec)
R = 0.979
y = x

94. Lupus Sensitivity Study to Serathan and Intrin Reagents Objective: Perform a Lupus sensitivity comparative study of Intrin-SI and Intrin-EA to Pacific Hemostasis’ Kontact and APTT-LS reagents.

95. Lupus Sensitivity Study Materials & Equipment Lupus Plasma Samples Serathan-A Reagent Serathan-B Reagent Pacific Hemostasis DS Reagent Pacific Hemostasis D Reagent Intrin-SI Reagent Intrin-EA Reagent Pacific Hemostasis Kontact Reagent Pacific Hemostasis APTT-LS Reagent 0.02 M CaCl2 Fibrometer 0.1, 0.2 Pipetter 0.1-1ml Volumetric Pipetter

96. Lupus Sensitivity Study
Procedure:
Twenty samples of positive anticoagulant Lupus samples from George King Biological (Lot GK g1) were measured by performing a PT on Wortham Laboratories Serathan-A (ISI=1.20) and Serathan-B (ISI=1.52) and Intrin reagents and comparing them to the predicate device Pacific Hemostasis Thromboplastin-DS (ISI=1.20) and Thromboplastin-D (ISI=1.54). APTT reagents Intrin-SI and Intrin-EA were measured against the Predicate Kontact and APTT-LS, a Kaolin and ellagic acid activator, respectively.

97. Lupus Sensitivity Study: Results
Sample
Serathan-A
Serathan-B
Thrombo-DS
Thrombo-D
Level 1
12.4
11.4
10.6
Level 2
36.0
22.4
35.2
21.7
Level 3
68.3
32.9
66.9
31.2 1
13.8
12.9
11.9 2
13.9
13.4 3
13.5 4 5
12.5 6 7 8 9 10
Mean
13.82
12.42
13.36
12.00 SD
0.040
0.273
0.200
%CV
0.29
0.32
2.04
1.67
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

98. Lupus Sensitivity Study: Results
Sample
Intrin-SI
Kontact
Intrin-EA
APTT-LS
Level 1
28.0
27.4
28.4
27.9
Level 2
40.4
39.4
41.3
Level 3
55.8
51.4
62.6
60.4 1
58.3
61.9
33.5
32.4 2
59.2
57.0
28.9 3
57.5
58.9
30.7 4
52.8
47.9
31.2 5
50.3
38.5
25.9 6
49.7
43.9 7
44.4
35.1 8
57.2
66.9
34.6
33.9 9
46.9
32.3 10
56.5
48.9
32.7
Mean
55.07
51.52
32.56
28.95 SD
3.51
8.65
1.43
2.26
%CV
6.37
16.80
4.39
7.81
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

99. Lupus Sensitivity Study: Conclusions
Although Lupus has little effect on the extrinsic system, clearly, only the PT reagents with a 1.20 ISI detected its anticoagulant effect. The silicone activator in both of the APTT reagents was sensitive to positive Lupus anticoagulant plasma, while the thromboplastin reagent with a ISI and the ellagic acid activator remained unresponsive. The stabilizers in the Wortham Laboratories reagents gave a more consistent reproducible result of the PT reagents Serathan-A and Serathan-B standard deviation to Thromboplastin-DS and Thromboplastin-D SD. Likewise, the stability of Intrin-SI and Intrin-EA produced a and SD, respectively, compared to the predicates Kontacts SD and APTT-LS SD.

100. Intrin-SI / Intrin-EA Linearity Study Objective: This study is to measure the linearity of Intrin-SI and Intrin-EA reagents.

101. Intrin-SI / Intrin-EA Linearity Study Materials & Equipment Stasis 1 Coagulation Control Sodium Heparin Intrin-SI Reagent Intrin-EA Reagent 0.02 M CaCl2 Pacific Hemostasis Kontact Pacific Hemostasis APTT-LS Fibrometer 0.1, 0.2 Pipetter ml Volumetric Pipetter

102. Intrin-SI / Intrin-EA Linearity Study : Procedure
A base heparin concentrate was prepared by adding 10 mg of Sigma Chemicals Sodium Heparin (H3393-1MU), lot 045K1819, to 182 ml Stasis 1 control.
Test samples were prepared by pipetting 10, 20, 30, 40 and 50 μl to 0.99, 0.98, 0.97, 0.96, 0.95 ml Stasis control, respectively, to produce 0.1, 0.2, 0.3, 0.4, and 0.5 U/ml heparin samples. This process was repeated 3 times for each APTT reagent.
Heparin linearity was measured by performing and APTT assay for each reagent.
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

103. Intrin-SI / Intrin-EA Linearity Study : RESULTS
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

104. Intrin-SI / Intrin-EA Linearity Study : RESULTS
Mean SD
%CV
Sample Intrin-SI Kontact Intrin-EA APTT-LS
Level
Level
Level
Mean SD
%CV

105. Intrin-SI / Intrin-EA Linearity Study
Conclusions:
Both Intrin-SI and Intrin-EA demonstrated linearity of 0-5 U/ml of heparin.

106. Product Inserts: Fibrinogen Control, Normal

107. Product Inserts: Fibrinogen Control, Normal
Intended Use
Wortham Laboratories Fibrinogen Control (Normal), a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.

108. Product Inserts: Fibrinogen Control, Normal
Summary and Principle
The thrombin clotting time fibrinogen assay is based on the method described by Clauss. In the presence of high concentrations of thrombin, the time required for clot formation in dilute plasma is inversely proportional to the fibrinogen concentrations.

109. Product Inserts: Fibrinogen Control, Normal
Expected Values
Values were assayed using thrombin clotting time (Clauss) methodology. Three lots of Wortham Laboratories Normal Fibrinogen Control was evaluated in singlicate on the BBL Fibrometer (n=180), the run-run mean fibrinogen level was 301 mg/dl and at ± 2SD range of mg/dl. Recovery values may vary with other procedures. Actual values recovered depend on the instrument and reagent used.

110. Product Inserts: Fibrinogen Control, Normal
Performance Characteristics
Wortham Laboratories Normal Fibrinogen Control plasma samples were tested on the BBL Fibrometer, yielding a within-run and run-run precision of 0.56% CV and 0.57% CV, respectively.

111. Product Inserts: Fibrinogen Control, Low

112. Product Inserts: Fibrinogen Control, Low
Intended Use
Wortham Laboratories Fibrinogen Control (Low), a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.

113. Product Inserts: Fibrinogen Control, Low
Summary and Principle
The thrombin clotting time fibrinogen assay is based on the method described by Clauss. In the presence of high concentrations of thrombin, the time required for clot formation in dilute plasma is inversely proportional to the fibrinogen concentrations.

114. Product Inserts: Fibrinogen Control, Low
Expected Values
Values were assayed using thrombin clotting time (Clauss) methodology. Three lots of Wortham Laboratories Low Fibrinogen Control was evaluated in singlicate on the BBL Fibrometer (n=180), the
run-run mean fibrinogen level of 99 mg/dl and a ± 2SD range of mg/dl. Recovery values may vary with other procedures. Actual values recovered depend on the instrument and reagent used.

115. Product Inserts: Fibrinogen Control, Low
Performance Characteristics
Wortham Laboratories Low Fibrinogen Control plasma samples were tested on the BBL Fibrometer, yielding a within-run and run-run precision of 0.60% CV and 0.58% CV, respectively.

116. Product Inserts: Heparin Control Level 1 (0.25 U/ml)

117. Product Inserts: Heparin Control Level 1 (0.25 U/ml)
Intended Use
Wortham Laboratories Heparin Control Level 1 is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.

118. Product Inserts: Heparin Control Level 1 (0.25 U/ml)
Summary and Principle
The anticoagulant heparin is used in the treatment of various thrombosis disorders, and for the prevention of thrombin formation during surgery. There are a number of assays available for the clinical laboratory to monitor heparin therapy. A critical component in these assays is the use of quality control plasmas, such as Wortham Laboratories Heparin Control Plasma Level 1 and 2.
Heparin affects the intrinsic coagulation pathway, prolonging the Activated Partial Thromboplastin Time (APTT) test. The APTT is a common screening test performed in the clinical laboratory. It is primarily used to detect certain factor deficiencies, however, it also can be used to monitor heparin therapy.

119. Product Inserts: Heparin Control Level 1 (0.25 U/ml)
Expected Values
Wortham Laboratories Heparin Control Plasma is dependent on the overall test system, which includes factors such as reagent, instrument, protocol and individual technique. However, the Heparin Control assayed on the BBL Fibrometer produced a mean APTT clotting time of 46.9 seconds and a ± 2SD range of seconds.

120. Product Inserts: Heparin Control Level 1 (0.25 U/ml)
Performance Characteristics
When using Heparin Control Level 1 Plasma as abnormal APTT control, within-run precision studies performed on the BBL Fibrometer using Wortham Laboratories Intrin-SI reagent yielded CV’s of 1.82 %, and a 1.77% CV for run-run assays.

121. Product Inserts: Heparin Control Level 2 (0.35 U/ml)

122. Product Inserts: Heparin Control Level 2 (0.35 U/ml)
Intended Use
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.

123. Product Inserts: Heparin Control Level 2 (0.35 U/ml)
Summary and Principle
The anticoagulant heparin is used in the treatment of various thrombosis disorders, and for the prevention of thrombin formation during surgery. There are a number of assays available for the clinical laboratory to monitor heparin therapy. A critical component in these assays is the use of quality control plasmas, such as Wortham Laboratories Heparin Control Plasma Level 1 and 2.
Heparin affects the intrinsic coagulation pathway, prolonging the Activated Partial Thromboplastin Time (APTT) test. The APTT is a common screening test performed in the clinical laboratory. It is primarily used to detect certain factor deficiencies, however, it also can be used to monitor heparin therapy.

124. Product Inserts: Heparin Control Level 2 (0.35 U/ml)
Expected Values
Wortham Laboratories Heparin Control Plasma is dependent on the overall test system, which includes factors such as reagent, instrument, protocol and individual technique. However, the Heparin Control assayed on the BBL Fibrometer produced a mean APTT clotting time of 63.5 seconds and a ± 2SD range of seconds.

125. Product Inserts: Heparin Control Level 2 (0.35 U/ml)
Performance Characteristics
When using Heparin Control Level 2 Plasma as abnormal APTT control, within-run precision studies performed on the BBL Fibrometer using Wortham Laboratories Intrin-SI reagent yielded CV’s of 1.92 %, and a 1.81% CV for run-run assays.

126. Product Inserts: Fibrinogen Assay Set (250 Determinations)

127. Product Inserts: Fibrinogen Assay Set
Intended Use
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control ( mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intended for use in the quantitative determination of fibrinogen in plasma samples.

128. Product Inserts: Fibrinogen Assay Set
Summary and Principle
The thrombin clotting time fibrinogen assay is based on the method described by Clauss. In the presence of high concentrations of thrombin, the time required for clot formation in dilute plasma is inversely proportional to the fibrinogen concentrations.

129. Product Inserts: Fibrinogen Assay Set
Expected Values
Laboratories should establish a normal control interval for fibrinogen measurement. Generally, the normal control is mg/dl.

130. Product Inserts: Fibrinogen Assay Set
Performance Characteristics
Accuracy
Three lots of normal and low fibrinogen plasmas were tested in singlicate with Wortham Laboratories reagents on the BBL Fibrometer. A summary of the results follows:
Control
Dilution n
Mean (sec) SD
Normal
1:6
180
15.08
0.087
Low
1:3
15.18
0.088

131. Product Inserts: Fibrinogen Assay Set
Performance Characteristics
Precision
Precision of the Normal and Low Fibrinogen Control result is dependent on many factors, such as the instrument, technique and the reagent used. A 1:6 and 1:8 dilution of 3 lots of the Normal and Low Fibrinogen Control respectively, were made and assayed in singlicate on the BBL Fibrometer. A summary of the results follow:
Control n
within-run
run-run
Normal 60
0.56% CV
180
0.57% CV
Low
0.60% CV
0.58% CV

132. Product Inserts: Fibrinogen Buffer

133. Product Inserts: Fibrinogen Buffer
Intended Use
Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.

134. Product Inserts: Thrombin Reagent

135. Product Inserts: Thrombin Reagent
Intended Use
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.

136. Product Inserts: Thrombin Reagent
Summary and Principle
The thrombin clotting time fibrinogen assay is based on the method described by Clauss. In the presence of high concentrations of thrombin, the time required for clot formation in dilute plasma is inversely proportional to the fibrinogen concentrations.

137. Product Inserts: Thrombin Reagent
Expected Values
Laboratories should establish a normal control interval for fibrinogen measurement. Generally, the normal control is mg/dl.

138. Product Inserts: Thrombin Reagent
Performance Characteristics
Accuracy
Three lots of normal and low fibrinogen plasmas were tested in singlicate with Wortham Laboratories reagents on the BBL Fibrometer. A summary of the results follows:
Control
Dilution n
Mean (sec) SD
Normal
1:6
180
15.08
0.087
Low
1:3
15.18
0.088

139. Product Inserts: Thrombin Reagent
Performance Characteristics
Precision
Precision of the Normal and Low Fibrinogen Control result is dependent on many factors, such as the instrument, technique and the reagent used. A 1:6 and 1:8 dilution of 3 lots of the Normal and Low Fibrinogen Control respectively, were made and assayed in singlicate on the BBL Fibrometer. A summary of the results follow:
Control n
within-run
run-run
Normal 60
0.56% CV
180
0.57% CV
Low
0.60% CV
0.58% CV

140. Product Inserts: Thrombin Reagent
Reportable Range/Linearity
The Thrombin Reagent (100IU/ml) when diluted %, demonstrated linearity from 100 IU/ml to 10 IU/ml.
Each laboratory should establish their own linearity using instrumentation, blood collection methods, and testing techniques used in the laboratory.

141. Product Inserts: Calcium Chloride 0.02M

142. Product Inserts: Calcium Chloride
Intended Use
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.

143. Coagulation Controls and Reagents: Real Time Stability Study

144. Real Time Stability Study
Objective
A real time stability study of the coagulation controls and reagents: StasisTM 1, 2 and 3, SerathanTM- A and B, IntrinTM – SI and EA, Fibrinogen, Thrombin, Heparin, when stored at °C and 4°C, is being conducted.

145. Real Time Stability Study
Materials and Methods
Coagulation Control Level I
Thromboplastin-D
Thromboplastin-DS
Kontact
APTT-LS
0.02 M CaCl2
Fibrinogen Assay Set
Heparin Control, Level I
WHO 2nd International Thrombin Standard, lot K.
12 x 75 tubes
15 ml polypropylene screw cap bottles
parafilm
37°C water bath
25°C incubator
2-4°C refrigerator
-10°C freezer

146. Real Time Stability Study
Procedures
The coagulation controls and reagents prepared from the accelerated stability studies, which were stored at -10°C, were used in this real time stability study. Testing was done one lot of each product and assayed on the BBL Fibrometer.
Samples of the coagulation products were tested daily for the first 30 days, one product at its study temperature at a time. All coagulation products stored at -2°C were thawed and refrozen for each test day, thereby, evaluating the product’s repetitive freeze-thaw capacity. Freshly prepared Pacific Hemostasis controls and reagents were used to measure the activity of the stressed samples. StasisTM controls were assayed for PT and APTT. Both SerathanTM and IntrinTM reagents were measured against a Level I coagulation control. The Fibrinogen Assay Set and Heparin Control were used to test the Low Fibrinogen and Level 1 Heparin stressed samples, respectively. The WHO 2nd International Thrombin Standard was used to measure the thrombin activity of the Thrombin Reagent stressed samples.

147. Real Time Stability Study
Conclusions
The first 30 days of the revised stability study, where the frozen storage has been changes from -10°C to -2°C, show no loss of activity. Real time studies will be ongoing.

148. 510(k) Summary: Stasis 1 Coagulation Control

149. 510(k): Stasis 1 Coagulation Control
Device Name:
Wortham Laboratories Stasis 1 Coagulation Control (Normal) #K060968
Common Name:
Normal Coagulation Control
Classification Name:
Plasma Coagulation Control, a Class II
device as per 21 CFR Section
(Product Code GGC). This device is
intended for clinical use in conjunction
with an analyzer to measure clot
formation.
Predicate:
Pacific Hemostasis Coagulation Control Level I (K984129)

150. 510(k): Stasis 1 Coagulation Control
Description
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.

151. 510(k): Stasis 1 Coagulation Control
Intended Use
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.

152. 510(k): Stasis 1 / Substantial Equivalence
Characteristics
Intended Use
New Device
Routine coagulation for PT, PTT, fibrinogen assays in the normal range
Predicate
Control Composition
Liquid Human citrated plasma
Lypholyzed human citrated plasma
Stability
12 ≤ -2° C
30 2-4° C
35 2-8° C, lypholyzed
8 2-8° C, rehydrated
Reference Values PT
CV%
within-run (ISI=1.54)
0.75%
0.90%
within-run (ISI=1.20)
0.88%
1.40%
run-run (ISI=1.54)
0.67%
0.85%
run-run (ISI=1.20)
0.89%
1.38%
APTT
within-run (Kaolin)
0.63%
1.54%
within-run (Ellagic-Acid)
0.62%
run-run (Kaolin)
0.61%
1.20%
run-run (Ellagic Acid)
0.60%

153. 510(k): Stasis 1 / Substantial Equivalence
Fibrinogen
CV%
within-run
0.56%
0.59%
run-run
0.57%
0.60%
Expected Range
Mechanical
Mean
± 2SD PT
11.67
sec
11.66
sec
APTT:
29.51
sec
28.38
sec
Fibrinogen:
306.3
g/dl
g/dl
Storage
≤ -2° C
2 - 8° C
Assay Factors
PT, APTT, Fibrinogen

154. 510(k): Stasis 1 - Conclusions
Wortham Laboratories Stasis 1 and Pacific Hemostasis Coagulation Control Level I have the same intended use, as normal controls for the quantitative measurement of the Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and fibrinogen levels. Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.
Mechanical assays of Stasis 1 to the predicate normal plasma control with two different sensitive thromboplastin reagents, with an ISI of 1.20 and 1.58, yielded a within-run standard deviation of and for Stasis 1 respectively, compared to a and a SD for the predicate control from the same reagents. A run-run precision of Stasis 1 produced a and SD with the two thromboplastin reagents, compared to and SD of Pacific Hemostasis Control.
Mechanical measurements of the APTT in both Stasis 1 and Pacific Hemostasis Level I Control with two different activator reagents, Kaolin and ellagic acid, produced a within-run and a standard deviation, respectively, while the predicate control yielded a and a SD. A run-run precision of the Stasis 1 Control measured at and SD to the two APTT activators, contrasted to Pacific Hemostasis Level I Controls and SD.

155. 510(k): Stasis 1 - Conclusions
The processing of the Fibrinogen levels in both study graphs on the fibrometer instrument produced a within-run and a run-run standard deviation for Stasis 1, which a within-run SD and run-run SD was observed in the Pacific Hemostasis Level 1 Control.
Reproducibility of the two controls yielded a 0.86% within-run coefficient of variation and a run-run 0.89% CV for Stasis 1, compared respectively to the predicate control of 1.36% CV and 1.38% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 1 Coagulation Control to Pacific Hemostasis Coagulation Control Level I. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

156. 510(k) Summary: Stasis 2 Coagulation Control

157. 510(k): Stasis 2 Coagulation Control
Device Name:
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) #K060968
Common Name:
Abnormal Coagulation Control
Classification Name:
Plasma Coagulation Control, a Class II
device as per 21 CFR Section
(Product Code GGC). This device is
intended for clinical use in conjunction
with an analyzer to measure clot
formation.
Predicate:
Pacific Hemostasis Coagulation Control Level II (K984130)

158. 510(k): Stasis 2 Coagulation Control
Description
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.

159. 510(k): Stasis 2 Coagulation Control
Intended Use
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.

160. 510(k): Stasis 2 / Substantial Equivalence
Characteristics
Intended Use
New Device
Routine coagulation for PT, PTT, assays in the moderately abnormal range
Predicate
Routine coagulation for PT, PTT, assays in the moderately abnormal range
Control Composition
Liquid Human citrated plasma
Lypholyzed human citrated plasma
Stability
12 ≤ -2° C
30 2-4° C
34 2-8° C, lypholyzed
8 2-8° C, rehydrated
Reference Values PT
CV%
within-run (ISI=1.54)
1.01%
1.41%
within-run (ISI=1.20)
1.10%
1.28%
run-run (ISI=1.54)
0.98%
1.30%
run-run (ISI=1.20)
1.19%

161. 510(k): Stasis 2 / Substantial Equivalence
APTT
CV%
within-run (Kaolin)
0.76%
1.00%
within-run (Ellagic-Acid)
0.50%
0.91%
run-run (Kaolin)
1.06%
run-run (Ellagic Acid)
0.48%
0.90%
Expected Range
Mechanical
Mean
± 2SD PT
20.14
sec
20.25
sec
APTT:
55.75
sec
55.01
sec
Storage
≤ -2° C
2 - 8° C
Assay Factors
PT, APTT

162. 510(k): Stasis 2 - Conclusions
Wortham Laboratories Stasis 2 and Pacific Hemostasis Coagulation Control Level II have the same intended use, as normal controls for the quantitative measurement of the Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.
Mechanical assays of Stasis 2 to the predicate moderately abnormal plasma control with two different sensitive thromboplastin reagents, 1.20 ISI and 1.58 ISI, yielded a standard deviation of and for Stasis 2 respectively, compared to a SD and a SD for the predicate control from the same reagents. A run-run precision of Stasis 2 produced a and SD with the two thromboplastin reagents, compared to and SD of Pacific Hemostasis Control.
Mechanical measurements of the APTT in both Stasis 2 and Pacific Hemostasis Level II Control with two different activator reagents, Kaolin and ellagic acid, produced a and a standard deviation, respectively, while the predicate control yielded a and a SD. A run-run precision of the Stasis 2 Control measured at and SD to the two APTT activators, contrasted to Pacific Hemostasis Level II Controls and SD.

163. 510(k): Stasis 2 - Conclusions
Reproducibility of the two controls yielded a 1.10% within-run coefficient of variation and a run-run 1.01% CV for Stasis 2, compared respectively to the predicate control of 1.28% CV and 1.19% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 2 Coagulation Control to Pacific Hemostasis Coagulation Control Level II. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

164. 510(k) Summary: Stasis 3 Coagulation Control

165. 510(k): Stasis 3 Coagulation Control
Device Name:
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) #K060968
Common Name:
Abnormal Coagulation Control
Classification Name:
Plasma Coagulation Control, a Class II
device as per 21 CFR Section
(Product Code GGC). This device is
intended for clinical use in conjunction
with an analyzer to measure clot
formation.
Predicate:
Pacific Hemostasis Coagulation Control Level III (K984131)

166. 510(k): Stasis 3 Coagulation Control
Description
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.

167. 510(k): Stasis 3 Coagulation Control
Intended Use
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.

168. 510(k): Stasis 3 / Substantial Equivalence
Characteristics
Intended Use
New Device
Routine coagulation for PT, PTT, assays in the high abnormal range
Predicate
Routine coagulation for PT, PTT, assays in the high abnormal range
Control Composition
Liquid Human citrated plasma
Lypholyzed human citrated plasma
Stability
12 ≤ -2° C
30 2-4° C
35 2-8° C, lypholyzed
8 2-8° C, rehydrated
Reference Values PT
CV%
within-run (ISI=1.54)
1.45%
1.68%
within-run (ISI=1.20)
1.36%
1.52%
run-run (ISI=1.54)
1.46%
1.70%
run-run (ISI=1.20)
1.44%
1.34%

169. 510(k): Stasis 3 / Substantial Equivalence
APTT
CV%
within-run (Kaolin)
0.80%
1.12%
within-run (Ellagic-Acid)
0.76%
run-run (Kaolin)
0.75%
1.15%
run-run (Ellagic Acid)
1.11%
Expected Range
Mechanical
Mean
± 2SD PT
32.50
sec
32.49
sec
APTT:
70.49
sec
70.13
sec
Storage
≤ -2° C
2 - 8° C
Assay Factors
PT, APTT

170. 510(k): Stasis 3 - Conclusions
Wortham Laboratories Stasis 3 and Pacific Hemostasis Coagulation Control Level III have the same intended use, as normal controls for the quantitative measurement of the Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.
Mechanical assays of Stasis 3 to the predicate moderately abnormal plasma control with two different sensitive thromboplastin reagents, 1.20 ISI and 1.58 ISI, yielded a standard deviation of and for Stasis 3 respectively, compared to a and a for the predicate control from the same reagents. A run-run precision of Stasis 3 produced a and SD with the two thromboplastin reagents, compared to and SD of Pacific Hemostasis Control.

171. 510(k): Stasis 3 - Conclusions
Mechanical measurements of the APTT in both Stasis 3 and Pacific Hemostasis Level III Control with two different activator reagents, Kaolin and ellagic acid, produced a and a standard deviation, respectively, while the predicate control yielded a and a SD. A run-run precision of the Stasis 3 Control measured at and SD to the two APTT activators, contrasted to Pacific Hemostasis Level III Controls and SD.
Reproducibility of the two controls yielded a 1.35% within-run coefficient of variation and a run-run 1.36% CV for Stasis 3, compared respectively to the predicate control of 1.52% CV and 1.58% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 3 Coagulation Control to Pacific Hemostasis Coagulation Control Level III. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

172. 510(k) Summary: Serathan-A PT Reagant

173. 510(k): Serathan-A PT Reagant
Device Name:
Wortham Laboratories Serathan-A PT Reagant #K060968
Common Name:
Prothrombin Time
Classification Name:
Prothrombin Time Test, is a Class II
device, as per 21 CFR
(Product Code GJS). This device is
intended for clinical use in conjunction
with an analyzer to measure clot
formation.
Predicate:
Pacific Hemostasis Thromboplastin DS (K940082)

174. 510(k): Serathan-A PT Reagant
Description
Wortham Laboratories Serathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.

175. 510(k): Serathan-A PT Reagant
Intended Use
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.

176. 510(k): Serathan-A / Substantial Equivalence
Characteristics
Intended Use
New Device
Performance of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway
Predicate
Reagent Composition
Liquid Rabbit Thromboplastin
Lypholyzed Rabbit Thromboplastin
Stability
12 ≤ -2° C
30 2-4° C
30 2-8° C, lypholyzed
7 2-8° C, rehydrated
Reference Values
within-run
CV%
Level 1
0.89%
1.36%
Level 2
1.09%
1.28%
Level 3
1.25%
1.52%
run-run
0.88%
1.38%
1.08%
1.19%
1.58%

177. 510(k): Serathan-A / Substantial Equivalence
Lupus Sensitivity
CV%
0.29%
2.04%
Factor Assay
Factor II
1.25%
0.42%
Factor V
0.25%
0.37%
Factor VII
0.38%
Factor X
0.18%
0.32%

178. 510(k): Serathan-A / Substantial Equivalence
Expected
Range
Mean (sec) % II V
VII X
100
11.79
11.99
11.90
11.69
11.67
11.80 50
13.41
12.79
13.11
11.72
13.31
12.70
12.98 40
12.02
14.20
13.60
11.92
14.09
12.92
13.51 30
12.38
15.20
13.82
14.52
12.30
15.13
13.72
14.38 20
12.99
16.29
14.11
15.21
12.80
16.22
14.02
15.10 10
14.31
18.66
15.51
17.52
18.48
15.38
17.30
Linearity
12.1 – 41.9 sec
11.9 – 41.1 sec
Storage
≤ -2° C
2 - 8° C
Assay Factors
PT, Fibrinogen, Factors
II, V, VII, X

179. 510(k): Serathan-A Conclusions
Wortham Laboratories Serathan-A and Pacific Hemostasis Thromboplastin-DS reagents have the same intended use, as for the quantitative measurement of the Prothrombin Time (PT), and Factors II, V, VII, X. Both reagents are preparations of rabbit thromboplastin and calcium chloride, with an International Sensitivity Index of 1.0 – 1.2.
All assays were measured on the fibrometer yielding a PT standard deviation of , and for Serathan-A on Level 1, Level 2, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Thromboplastin-DS of , , standard deviation on the same controls.
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.030, 0.030, and for Factors II, V, VII, X, respectively for Serathan-A, contrasted to , 0.043, 0.045, and for Thromboplastin-DS.

180. 510(k): Serathan-A Conclusions
Reproducibility of the two reagents yielded a 1.09% within-run coefficient of variation and a run-run 0.97% CV for Serathan-A, compared respectively to the predicate control of 1.18% CV and 1.21% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Serathan-A to Pacific Hemostasis Thromboplastin-DS. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

181. 510(k) Summary: Serathan-B PT Reagant

182. 510(k): Serathan-B PT Reagant
Device Name:
Wortham Laboratories Serathan-B PT Reagant #K060968
Common Name:
Prothrombin Time
Classification Name:
Prothrombin Time Test, is a Class II
device, as per 21 CFR
(Product Code GJS). This device is
intended for clinical use in conjunction
with an analyzer to measure clot
formation.
Predicate:
Pacific Hemostasis Thromboplastin D (K994100)

183. 510(k): Serathan-B PT Reagant
Description
Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.

184. 510(k): Serathan-B PT Reagant
Intended Use
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.

185. 510(k): Serathan-B / Substantial Equivalence
Characteristics
Intended Use
New Device
Performance of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway
Predicate
Reagent Composition
Liquid Rabbit Thromboplastin
Lypholyzed Rabbit Thromboplastin
Stability
12 ≤ -2° C
30 2-4° C
30 2-8° C, lypholyzed
7 2-8° C, rehydrated

186. 510(k): Serathan-B / Substantial Equivalence
Reference Values
within-run
CV%
Level 1
0.80%
0.90%
Level 2
1.27%
1.41%
Level 3
1.42%
1.68%
run-run
0.75%
0.85%
1.22%
1.30%
1.44%
1.70%
Lupus Sensitivity
0.32%
1.67%
Factor Assay
Factor II
0.00%
0.39%
Factor V
0.26%
Factor VII
0.19%
Factor X
0.31%

187. 510(k): Serathan-B / Substantial Equivalence
Expected
Range
Mean (sec) % II V
VII X
100
11.00
11.49
11.40
11.60
10.88
11.38
11.28
11.48 50
11.01
11.89
12.41
11.39
11.80
12.32
13.13 40
13.09
13.82
11.41
12.29
12.92
13.56 30
11.79
13.19
13.90
14.91
11.70
13.00
13.71
14.73 20
12.30
14.70
14.79
16.32
12.22
14.50
16.08 10
17.12
16.48
20.02
13.63
16.93
16.17
19.81
Linearity
11.6 – 36.2 sec
11.1 – 35.6 sec
Storage
≤ -2° C
2 - 8° C
Assay Factors
PT, Fibrinogen, Factors
II, V, VII, X

188. 510(k): Serathan-B Conclusions
Wortham Laboratories Serathan-B and Pacific Hemostasis Thromboplastin-D reagents have the same intended use, as for the quantitative measurement of the Prothrombin Time (PT), and Factors II, V, VII, X. Both reagents are preparations of rabbit thromboplastin and calcium chloride, with an International Sensitivity Index of 1.5 – 1.7.
All assays were measured on the fibrometer yielding a PT standard deviation of , and for Serathan-B on Level 1, Level 2, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Thromboplastin-D of , , standard deviation on the same controls.
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.03, 0.03, and for Factors II, V, VII, X, respectively for Serathan-B, contrasted to 0.043, 0.036, 0.036, and for Thromboplastin-D.

189. 510(k): Serathan-B Conclusions
Reproducibility of the two reagents yielded a 0.80% within-run coefficient of variation and a run-run 0.75% CV for Serathan-B, compared respectively to the predicate control of 0.91% CV and 0.89% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Serathan-B to Pacific Hemostasis Thromboplastin-D. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

190. 510(k) Summary: Intrin-SI APTT Reagent

191. 510(k): Intrin-SI APTT Reagent
Device Name:
Wortham Laboratories Intrin-SI APTT Reagant #K060968
Common Name:
Activated Partial Thromboplastin Time (APTT)
Classification Name:
Activated Partial Thromboplastin is a Class II
device, as per 21 CFR (Product Code
GFO). This device is intended for clinical use
in conjunction with an analyzer to measure
clot formation.
Predicate:
Pacific Hemostasis Kontact (K023362)

192. 510(k): Intrin-SI APTT Reagent
Description
Wortham Laboratories Intrin-SI APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator Kaolin.

193. 510(k): Intrin-SI APTT Reagent
Intended Use
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.

194. 510(k): Intrin-SI / Substantial Equivalence
Characteristics
Intended Use
New Device
Performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway
Predicate
Reagent Composition
Liquid Rabbit Thromboplastin with a silicon activator
Stability
12 ≤ -2° C
30 2-4° C
12 2-8° C
30 2-8° C, open

195. 510(k): Intrin-SI / Substantial Equivalence
Reference Values
within-run
CV%
Level 1
0.29%
1.54%
Level 2
0.74%
1.00%
Level 3
0.75%
1.16%
run-run
1.20%
1.01%
1.15%
Heparin Sensitivity
0.25 U/ml
1.57%
2.30%
0.35 U/ml
1.53%
2.02%
Lupus Sensitivity
6.37%
16.80%
Factor Assay
Factor VIII
0.13%
0.31%
Factor IX
0.10%
0.32%
Factor XI
0.16%
0.26%
Factor XII
0.18%
0.34%

196. 510(k): Intrin-SI / Substantial Equivalence
Expected
Range
Mean (sec) %
VIII IX XI
XII
100
28.52
29.59
29.17
28.56
27.85
28.12
28.05
27.78 50
34.77
32.78
30.35
33.75
34.08
31.38
29.26 40
38.02
35.80
34.23
36.14
37.21
34.80
33.13 30
42.31
42.61
39.57
37.83
40.90
41.74
38.52
36.64 20
49.91
50.22
46.00
41.59
47.22
49.16
45.15
40.31 10
57.21
56.14
53.68
48.83
54.18
55.12
52.32
47.67
Storage
≤ -2° C
2 - 8° C
Assay Factors
APTT, Heparin, Factors
VIII, IX, XI, XII

197. 510(k): Intrin-SI Conclusions
Wortham Laboratories Intrin-SI and Pacific Hemostasis Kontact reagents have the same intended use, as for the quantitative measurement of the Activated Partial Thromboplastin Time (APTT), Heparin, and Factors VIII, IX, XI, XII. Both reagents are preparations of rabbit thromboplastin and a silicon activator from kaolin.
All assays were measured on the fibrometer yielding an APTT standard deviation of , and for Intrin-SI on Level 1, Level 2, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Kontact of , , standard deviation on the same controls.
Intrin-SI sensitivity to heparin at 0.25 U/ml and 0.35 U/ml, yielded a standard deviation to both levels of heparin compared to and standard deviation, respectively, in the predicate product.

198. 510(k): Intrin-SI Conclusions
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.036, 0.030, 0.046, and SD for Factors VIII, IX, XI, XII, respectively for Intrin-SI, to 0.087, 0.089, 0.074, and SD for Kontact.
Reproducibility of the two reagents yielded a 0.67% coefficient of variation at 0.25 U/ml and 0.48% CV at 0.35 U/ml heparin, compared to Kontact 0.94% CV and 0.72% CV, respectively.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Intrin-SI to Pacific Hemostasis Kontact. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

199. 510(k) Summary: Intrin-EA APTT Reagent

200. 510(k): Intrin-EA APTT Reagent
Device Name:
Wortham Laboratories Intrin-SI APTT Reagant #K060968
Common Name:
Activated Partial Thromboplastin Time (APTT)
Classification Name:
Activated Partial Thromboplastin is a Class II
device, as per 21 CFR (Product Code
GFO). This device is intended for clinical use
in conjunction with an analyzer to measure
clot formation.
Predicate:
Pacific Hemostasis APTT-LS (K891337)

201. 510(k): Intrin-EA APTT Reagent
Description
Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid.

202. 510(k): Intrin-EA APTT Reagent
Intended Use
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.

203. 510(k): Intrin-EA / Substantial Equivalence
Characteristics
Intended Use
New Device
Performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway
Predicate
Reagent Composition
Liquid Rabbit Thromboplastin with ellagic acid activator
Stability
12 ≤ -2° C
30 2-4° C
22 2-8° C, lypholyzed
30 2-8° C, rehydrated

204. 510(k): Intrin-EA / Substantial Equivalence
Reference Values
within-run
CV%
Level 1
0.51%
0.85%
Level 2
0.41%
0.91%
Level 3
0.73%
1.12%
run-run
0.44%
0.90%
0.71%
1.11%
Heparin Sensitivity
0.25 U/ml
1.03%
0.35 U/ml
0.54%
Lupus Sensitivity
4.39%
7.81%
Factor Assay
Factor VIII
0.17%
0.23%
Factor IX
0.24%
Factor XI
0.14%
0.29%
Factor XII
0.13%
0.26%

205. 510(k): Intrin-EA / Substantial Equivalence
Expected
Range
Mean (sec) %
VIII IX XI
XII
100
29.36
28.54
29.47
26.82
28.23
27.48
28.32
25.78 50
33.86
32.38
34.74
29.89
32.57
31.26
33.36
28.65 40
35.08
34.03
36.26
31.14
33.83
33.02
35.03
29.78 30
37.33
36.34
38.61
32.23
36.13
35.12
37.30
31.09 20
40.47
38.64
41.35
33.33
39.20
37.40
40.14
32.04 10
45.10
40.89
46.84
35.04
43.78
39.86
45.70
33.21
Linearity
29.0 – 70.7 sec
28.5 – 69.6 sec
Storage
≤ -2° C
2 - 8° C
Assay Factors
APTT, Heparin, Factors
VIII, IX, XI, XII

206. 510(k): Intrin-EA Conclusions
Wortham Laboratories Intrin-EA and Pacific Hemostasis APTT-LS reagents have the same intended use, as for the quantitative measurement of the Activated Partial Thromboplastin Time (APTT), Heparin, and Factors VIII, IX, XI, XII. Both reagents are preparations of rabbit thromboplastin and ellagic acid as an activator.
All assays were measured on the fibrometer yielding an APTT standard deviation of , and for Intrin-EA on Level 1, Level 2, Level 3 plasma controls, respectively, compared to Pacific Hemostasis APTT-LS of , , standard deviation on the same controls.
Intrin-EA sensitivity to heparin at 0.25 U/ml and 0.35 U/ml, yielded a standard deviation to both levels of heparin compared to and standard deviation, respectively, in the predicate product.

207. 510(k): Intrin-EA Conclusions
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.049, 0.048, 0.043, and SD for Factors VIII, IX, XI, XII, respectively for Intrin-EA, to 0.064, 0.065, 0.083, and SD for APTT-LS.
Reproducibility of the two reagents yielded a 0.71% coefficient of variation at 0.25 U/ml and 0.54% CV at 0.35 U/ml heparin, compared to APTT-LS 1.03% CV and 0.91% CV, respectively.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Intrin-EA to Pacific Hemostasis APTT-LS. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

208. 510(k) Summary: Fibrinogen Control Plasma (Normal)

209. 510(k): Fibrinogen Control Plasma (Normal)
Device Name:
Wortham Laboratories Fibrinogen Control Plasma (Normal) #K060968
Common Name:
Fibrinogen Control Plasma
Classification Name:
Plasma, Coagulation Control, is a Class II
device as per 21 CFR
(Product Code GHH). This device is intended
for clinical use in conjunction with an
analyzer to measure clot formation.
Predicate:
Pacific Hemostasis Fibrinogen Assay
(K800826)

210. 510(k): Fibrinogen Control Plasma
Description
Wortham Laboratories Fibrinogen Normal Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.

211. 510(k): Fibrinogen Control Plasma
Intended Use
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.

212. 510(k): FCP / Substantial Equivalence
Characteristics
Intended Use
New Device
To determine quantitative level of fibrinogen in plasma sample, and for quality control in monitoring heparin therapy with APTT testing
Predicate
Control Composition
Liquid Human citrated plasma
Lypholyzed Human citrated plasma
Stability
12 ≤ -2° C
30 2-4° C
24 2-8° C, lypholyzed
16 2-8° C, rehydrated

213. 510(k): FCP / Substantial Equivalence
Reference Values
within-run
CV%
Normal
0.56%
0.59%
Low
0.60%
0.63%
run-run
0.57%
0.58%
0.67%
Expected Range
Mechanical
Mean
± 2SD
306.3
g/dl
g/dl
99.1
g/dl
99.8
g/dl
Storage
≤ -2° C
2 - 8° C
Assay Factors
Fibrinogen

214. 510(k): Fibrinogen Control Plasma - Normal Conclusions
Wortham Laboratories Normal Fibrinogen Control and Pacific Hemostasis Normal Fibrinogen Control have the same intended use, as for the quantitative measurement of fibrinogen levels in human plasma. Both are preparations of citrated human plasma, obtained from normal donors with added stabilizers and buffers.
Mechanical assays produced a standard deviation of for Wortham Laboratories Fibrinogen Control, compared to a standard deviation for Pacific Hemostasis Fibrinogen Control.
Reproducibility of the two controls yielded a 0.56% within-run coefficient of variation and a run-run 0.53% CV for Wortham Laboratories Fibrinogen Control compared respectively to the predicate control of 0.59% CV and 0.60% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Normal Fibrinogen Control to Pacific Hemostasis Normal Fibrinogen Control. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

215. 510(k) Summary: Fibrinogen Control Plasma (Low)

216. 510(k): Fibrinogen Control Plasma (Low)
Device Name:
Wortham Laboratories Fibrinogen Control Plasma (Low) #K060968
Common Name:
Fibrinogen Control Plasma
Classification Name:
Plasma, Coagulation Control, is a Class II
device as per 21 CFR
(Product Code GHH). This device is intended
for clinical use in conjunction with an
analyzer to measure clot formation.
Predicate:
Pacific Hemostasis Fibrinogen Assay
(K800826)

217. 510(k): Fibrinogen Control Plasma
Description
Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.

218. 510(k): Fibrinogen Control Plasma (Low)
Intended Use
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.

219. 510(k): FCP / Substantial Equivalence
Characteristics
Intended Use
New Device
To determine quantitative level of fibrinogen in plasma sample, and for quality control in monitoring heparin therapy with APTT testing
Predicate
Control Composition
Liquid Human citrated plasma
Lypholyzed Human citrated plasma
Stability
12 ≤ -2° C
30 2-4° C
24 2-8° C, lypholyzed
16 2-8° C, rehydrated

220. 510(k): FCP / Substantial Equivalence
Reference Values
within-run
CV%
Normal
0.56%
0.59%
Low
0.60%
0.63%
run-run
0.57%
0.58%
0.67%
Expected Range
Mechanical
Mean
± 2SD
306.3
g/dl
g/dl
99.1
g/dl
99.8
g/dl
Storage
≤ -2° C
2 - 8° C
Assay Factors
Fibrinogen

221. 510(k): Fibrinogen Control Plasma - Low Conclusions
Wortham Laboratories Low Fibrinogen Control and Pacific Hemostasis Low Fibrinogen Control have the same intended use, as for the quantitative measurement of fibrinogen levels in human plasma. Both are preparations of citrated human plasma, obtained from normal donors with added stabilizers and buffers.
Mechanical assays produced a standard deviation of for Wortham Laboratories Fibrinogen Control, compared to a standard deviation for Pacific Hemostasis Fibrinogen Control.
Reproducibility of the two controls yielded a 0.60% within-run coefficient of variation and a run-run 0.58% CV for Wortham Laboratories Fibrinogen Control compared respectively to the predicate control of 0.63% CV and 0.67% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Low Fibrinogen Control to Pacific Hemostasis Low Fibrinogen Control. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

222. 510(k) Summary: Heparin Control Plasma Level 1

223. 510(k): Heparin Control Plasma 1
Device Name:
Wortham Laboratories Heparin Control Plasma (Level 1) #K060968
Common Name:
Heparin Control Plasma Level 1
Classification Name:
Plasma, Coagulation Control, is a Class II
device as per 21 CFR
(Product Code GGN). This device is intended
for clinical use in conjunction with an
analyzer to measure clot formation.
Predicate:
Pacific Hemostasis Heparin Control Level 1
(K992278)

224. 510(k): Heparin Control Plasma 1
Description
Wortham Laboratories Heparin Control Level 1 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.

225. 510(k): Heparin Control Plasma 1
Intended Use
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.

226. 510(k): Heparin Control Plasma 1 Substantial Equivalence
Characteristics
Intended Use
New Device
Used in heparin assay for quality control in monitoring heparin therapy with APTT testing, yielding slightly abnormal range for Level 1 (0.25 U/ml) and marked abnormal range for Level 2 (0.35 U/ml)
Predicate
Control Composition
Liquid Human citrated plasma with heparin
Lypholyzed Human citrated plasma with heparin
Stability
12 ≤ -2° C
30 2-4° C
36 2-8° C, lypholyzed
8 2-8° C, rehydrated

227. 510(k): Heparin Control Plasma 1 Substantial Equivalence
Reference Values
within-run
CV%
0.25 U/ml
1.82%
2.14%
0.35 U/ml
1.77%
2.04%
run-run
1.92%
2.27%
1.81%
2.07%
Expected Range
Mechanical
Mean
± 2SD
Level 1
46.82
sec
46.94
sec
Level 2
63.49
sec
62.64
sec
Storage
≤ -2° C
2 - 8° C
Assay Factors
Heparin

228. 510(k): Heparin Control Plasma 1 Conclusions
Wortham Laboratories Heparin Control Level 1 and Pacific Hemostasis Heparin Control Level 1 have the same intended use, as for quality control in monitoring heparin therapy with APTT testing. Both are prepared from porcine heparin in normal human citrated plasma. The APTT value will be in the slightly abnormal range for Level 1 Heparin Control.
Mechanical assays produced a within-run standard deviation of and a run-run standard deviation for Wortham Laboratories Level 1 Heparin Control, compared to the predicate control of and standard deviation, respectively.

229. 510(k): Heparin Control Plasma 1 Conclusions
Reproducibility of the two controls yielded a 1.33% within-run coefficient of variation and a run-run 1.92% CV for Wortham Laboratories Heparin Control Level 1, compared respectively to the predicate control of 2.15% CV and 2.27% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Heparin Control Level 1 to Pacific Hemostasis Heparin Control Level 1. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

230. 510(k) Summary: Heparin Control Plasma Level 2

231. 510(k): Heparin Control Plasma 2
Device Name:
Wortham Laboratories Heparin Control Plasma (Level 2) (0.35 U/ml). #K060968
Common Name:
Heparin Control Plasma Level 2
Classification Name:
Plasma, Coagulation Control, is a Class II
device as per 21 CFR
(Product Code GGN). This device is intended
for clinical use in conjunction with an
analyzer to measure clot formation.
Predicate:
Pacific Hemostasis Heparin Control Level II
(K992279)

232. 510(k): Heparin Control Plasma 2
Description
Wortham Laboratories Heparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.

233. 510(k): Heparin Control Plasma 2
Intended Use
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.

234. 510(k): Heparin Control Plasma 2 Substantial Equivalence
Characteristics
Intended Use
New Device
Used in heparin assay for quality control in monitoring heparin therapy with APTT testing, yielding slightly abnormal range for Level 1 (0.25 U/ml) and marked abnormal range for Level 2 (0.35 U/ml)
Predicate
Control Composition
Liquid Human citrated plasma with heparin
Lypholyzed Human citrated plasma with heparin
Stability
12 ≤ -2° C
30 2-4° C
36 2-8° C, lypholyzed
8 2-8° C, rehydrated

235. 510(k): Heparin Control Plasma 2 Substantial Equivalence
Reference Values
within-run
CV%
0.25 U/ml
1.82%
2.14%
0.35 U/ml
1.77%
2.04%
run-run
1.92%
2.27%
1.81%
2.07%
Expected Range
Mechanical
Mean
± 2SD
Level 1
46.82
sec
46.94
sec
Level 2
63.49
sec
62.64
sec
Storage
≤ -2° C
2 - 8° C
Assay Factors
Heparin

236. 510(k): Heparin Control Plasma 2 Conclusions
Wortham Laboratories Heparin Control Level 2 and Pacific Hemostasis Heparin Control Level 2 have the same intended use, as for quality control in monitoring heparin therapy with APTT testing. Both are prepared from porcine heparin in normal human citrated plasma. The APTT value will be in the slightly abnormal range for Level 2 Heparin Control.
Mechanical assays produced a within-run standard deviation of and a run-run standard deviation for Wortham Laboratories Level 2 Heparin Control, compared to the predicate control of and standard deviation, respectively.

237. 510(k): Heparin Control Plasma 2 Conclusions
Reproducibility of the two controls yielded a 1.77% within-run coefficient of variation and a run-run 1.81% CV for Wortham Laboratories Heparin Control Level 2, compared respectively to the predicate control of 2.047% CV and 2.07% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Heparin Control Level 2 to Pacific Hemostasis Heparin Control Level 2. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

238. 510(k) Summary: Fibrinogen Assay Set

239. 510(k): Fibrinogen Assay Set
Device Name:
Wortham Laboratories Fibrinogen Assay Set #K060968
Common Name:
Fibrinogen Control Plasma
Classification Name:
Plasma, Coagulation Control, is a Class II
device as per 21 CFR
(Product Code GHH). This device is intended
for clinical use in conjunction with an
analyzer to measure clot formation.
Predicate:
Pacific Hemostasis Fibrinogen Assay
(K800826)

240. 510(k): Fibrinogen Assay Set
Description
Wortham Laboratories Fibrinogen Assay Set contains a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers, buffers, and a bovine reagent and buffer solution which are also provided in the set. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.

241. 510(k): Fibrinogen Assay Set
Intended Use
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control ( mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intended for use in the quantitative determination of fibrinogen in plasma samples.

242. 510(k): Fibrinogen Assay Set Substantial Equivalence
Characteristics
Intended Use
New Device
To determine quantitative level of fibrinogen in plasma sample, and for quality control in monitoring heparin therapy with APTT testing
Predicate
Reagent Composition
Liquid Bovine Thrombin
Lypholyzed Bovine Thrombin
Stability
12 ≤ -2° C
30 2-4° C
24 2-8° C, lypholyzed
16 2-8° C, rehydrated

243. 510(k): Fibrinogen Assay Set Substantial Equivalence
Reference Values
within-run
CV%
Normal
0.56%
0.59%
Low
0.60%
0.63%
run-run
0.57%
0.58%
0.67%
Expected Range
Mechanical
Mean
± 2SD
306.3
g/dl
g/dl
99.1
g/dl
99.8
g/dl
Storage
≤ - 2° C
2 - 8° C
Assay Factors
Fibrinogen

244. 510(k): Fibrinogen Assay Set Conclusions
Wortham Laboratories Fibrinogen Assay Set and Pacific Hemostasis Fibrinogen Assay Set have the same intended use, as for the quantitative measurement of fibrinogen levels in human plasma. Both are preparations of citrated human plasma, obtained from normal donors with added stabilizers and buffers, and using bovine thrombin as the activating reagent.
Mechanical assays produced a standard deviation of for Wortham Laboratories Fibrinogen Control, compared to a standard deviation for Pacific Hemostasis Fibrinogen Control.

245. 510(k): Fibrinogen Assay Set Conclusions
Reproducibility of the two controls yielded a 0.56% within-run coefficient of variation and a run-run 0.53% CV for Wortham Laboratories Fibrinogen Control compared respectively to the predicate control of 0.59% CV and 0.60% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Fibrinogen Assay Set to Pacific Hemostasis Fibrinogen Assay Set. Based on the data provided, it is our conclusion that these two products are substantially equivalent.

246. 510(k) Summary: Thrombin Reagent

247. 510(k): Thrombin Reagent Device Name: Common Name:
Wortham Laboratories Thrombin Reagent #K060968
Common Name:
Thrombin Time Test
Classification Name:
Fibrinogen Determination System, Class II, 21 CFR
(Product Code GJA and KQJ). This device is intended for clinical use in conjunction with an analyzer to measure clot formation.
Predicate:
Pacific Hemostasis Thrombin Reagent (K970645)

248. 510(k): Thrombin Reagent Description
Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine prothrombin proteins (Factor IIa).
Intended Use
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.

249. 510(k): Thrombin Reagent Substantial Equivalence
Characteristics
Intended Use
New Device
To determine quantitative level of fibrinogen in plasma sample.
Predicate
Reagent Composition
Liquid bovine thrombin
Lypholyzed bovine thrombin
Stability
12 ≤ -2° C
30 2-4° C
28 2-8° C, lypholyzed
1 2-8° C, rehydrated

250. 510(k): Thrombin Reagent Substantial Equivalence
Reference Values
CV%
within-run
0.67%
0.68%
run-run
0.71%
Expected Range
Mechanical
Mean
± 2SD
119
IU/ml
Storage
≤ -2° C
2 - 8° C
Assay Factors
Fibrinogen

251. 510(k): Thrombin Reagent Conclusions
Wortham Laboratories Thrombin Reagent and Pacific Hemostasis Thrombin Reagent have the same intended use, as normal reagents for reactive coagulation assays. Both are preparations of activated bovine prothrombin protein (Factor IIa).
The performance data presented here, as well as the indistinguishable intended use and technological characteristics, support the substantial equivalence claim for Wortham Laboratories Thrombin Reagent to Pacific Hemostasis Thrombin Reagent.
Based on the data provided, it is our conclusion that these two products are substantially equivalent.

252. Wortham
Labels and Cartons

253. StasisTM Labeling

254. SerathanTM Labeling

255. IntrinTM + Others:

256. Required Carton Labeling

257. Required Carton Labeling
Wortham Laboratories, Inc.
Composition: Stasis 1 Control, a frozen liquid preparation, is processed from human plasma collected with 3.2% sodium citrate anticoagulant, with stabilizers and buffers added for a liquid control.
Caution: Human source plasma used in the product was tested by FDA approved methods and found to be negative for immunodeficiency virus (HIV) 1 and 2, hepatitis B virus (HBV), and hepatitis C (HCV). Since no test method can offer complete assurance that infectious agents are absent, extreme care should be taken.
Intended Use: Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.
For in vitro diagnostic use Cat No:
IVD

258. Marketing Success and Strategy
Wortham
Marketing Success and Strategy

259. Product Contrast: A D V A N T A G E S
All liquid system
1 year shelf life
Ready to use; no downtime
No waste
Low product coefficient of variation (%CV)
Repetitive freeze-thaw stability
Less storage space
Sensitivity to coagulation therapy

260. Sales Strategy: T A R G E T
The market consists of two groups. A. Laboratories with existing reagent contract B. Laboratories without a reagent contract in place
Laboratory most likely to have a reagent contract: A. Large to medium sized hospitals. B. Large to medium sized reference laboratories
Laboratory most likely not to have a reagent contract: A. Small hospitals and medical / surgical clinics B. Private medical laboratories / Private practice C. Veterinary hospitals

261. Sales Strategy: T A R G E T
Laboratories WITH reagent contracts. It is necessary to have our products evaluated one year before their contract expires.
Determine the responsible party: Locate the decision maker with signing authority. Local: Laboratory Director or Laboratory Manager Corporate: VP of New Products / Purchasing Officer

262. Service Excellence: Reagent Contract
Wortham Laboratories will offer a unique Reagent Contract
to our customers.
What makes our Reagent Contract different?
Any type or model of coagulation instrument can be acquired
Not limited only to the competitor’s instrument
No need to switch to an inferior coagulation product line or a product line that cost more, in order to obtain a specific instrument

263. Service Excellence: Maintenance
A Service Maintenance Contract covering limits beyond the
instrument warranty can be added to the Reagent Contract.
Market Leading Customer Service
In time, a pool of Customer Service staff members will be able to
speak to our customers in the following languages:
English
Arabic
Spanish
Hebrew
Portugese
Mandarin
German
Japanese
French
Korean
Italian
Tagalong

264. Presentation is Complete. T h a n k Y o u
Wortham
Wortham Laboratories, Inc.
©2007 Wortham Laboratories, Inc. All Rights Reserved International Office: USA