# K060968: Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low

- Pathway: 510(k) (Traditional)
- Applicant: Wortham Laboratories, Inc.
- Decided: May 15, 2007 after 403 days
- Product code: GIZ (Plasma, Control, Normal)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771346 (1977). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984129: Coagulation Control Level 1 (Normal), Pacific Hemostasis (1998) Summary page 1.
- K984130: Coagulation Control Level 2 (Abnormal), Pacific Hemostasis (1998) Summary page 4.
- K984131: Coagulation Control Level 3 (Abnormal), Pacific Hemostasis (1998) Summary page 7.
- K994100: Pacific Hemostasis Thromboplastin D, Pacific Hemostasis (2000) Summary page 10.
- K940082: Thromboscreen Thromboplastin-DS, Pacific Hemostasis (1995) Summary page 13.
- K891337: Thromboscreen Aptt Reagent, Pacific Hemostasis (1989) Summary page 16.
- K023362: Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin, Fisher Diagnostics (2002) Summary page 19.
- K800826: Fibrinogen Screen, Pacific Hemostasis (1980) Summary page 22.
- K970645: BC Thrombin Reagent, Behring Diagnostics, Inc. (1997) Summary page 26.
- K992278: Heparin Control Plasma Level 1, Pacific Hemostasis (1999) Summary page 28.
- K992279: Heparin Control Plasma Level 2, Pacific Hemostasis (1999) Summary page 30.

## Indications for use
Wortham Laboratories Stasis I 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. 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. 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. 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. 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. 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. Worthamt 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. Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays. Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays. Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples. Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mng/dl), Thrombin Reagent (100 IU/mi), and Fibrinogen Buffer, is intended for use in the quantitative determination of fibrinogen in plasma samples. Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring. Worthamn Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring. Wortham Laboratories Calcium Chloride Solution 0.02 M (CaC1 2) 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. Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.

Source page: https://510kreport.com/device/K060968
Methodology: https://510kreport.com/methodology