# K043571: Cryocheck Clot S

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic, Inc.
- Decided: Mar 18, 2005 after 81 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913424 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913424: Staclot (R) Protein S Test Kit, American Bioproducts Co. (1991) Summary page 1.

## Indications for use
CRYocheckA Clot S- is a clot-based assay intended for the quantitative determination of protein S activity in citrated human plasma. c¢RYOcheck- Clot S- is used to diagnose protein S deficiency (congenital or acquired) which is indicative of an increased risk of thromboembolism. A deficiency in protein S may produce recurrent thrombotic episodes. Congenital deficiencies of protein S are classified as three types: * type I deficiencies correspond to reduced antigen levels of both total and free protein S * type II deficiencies are characterized by a reduced protein S activity but with normal antigen levels of both total and free protein S * type III deficiencies are defined by a reduced antigen level and activity of free protein S but the antigen level of total protein S remains normal Acquired protein S deficiencies are associated with several clinical states: - oral anticoagulant therapy - liver disease - disseminated intravascular coagulation * oral contraceptives * oestrogen therapy * acute phase inflammatory responses * pregnancy · newborns

Source page: https://510kreport.com/device/K043571
Methodology: https://510kreport.com/methodology