# K971227: Cryo Check Factor X Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologicals, Inc.
- Decided: Jul 18, 1997 after 107 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor X is a two-chain molecule with a molecular weight of 59,000 and is important for both intrinsic and extrinsic coagulation. Factor X deficiency is commonly diagnosed in vitro through the used of a modified prothrombin time (PT) assay. When a patient sample is mixed with factor X deficient plasma, the degree of correction of the PT is proportional to the level of Factor X in the patient plasma. CryoCheck Factor X Deficient Plasma is human plasma deficient in the factor X coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor X deficiencies in in vitro clot-based factor X assays using the one stage prothrombin time.

Source page: https://510kreport.com/device/K971227
Methodology: https://510kreport.com/methodology