# K990814: Cryo Check Factor 2 Deficient Plasma, Models FDPO2-10, FDP02-15

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Jun 7, 1999 after 88 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- 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 K900906 (1990). 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)
- K900906: Factor II Deficient Plasma, Sigma Chemical Co. (1990) Summary page 2.

## Indications for use
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor II (also known as prothrombin) is a serine protease located in the “common coagulation pathway” and is essential to normal hemostasis. Factor II deficiency is commonly diagnosed in vitro through the use of a modified prothrombin time (PT) assay. Cryov'Check™ Factor 2 Deficient Plasma is human plasma deficient in the Factor II coagulation protein while having all other coagulation factors within normal limits. It is recommended for use as a substrate in clot-based Factor II assays using the one stage prothrombin time (PT).

Source page: https://510kreport.com/device/K990814
Methodology: https://510kreport.com/methodology