# K971224: Cryo Check Factor Vii Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologicals, Inc.
- Decided: Jul 17, 1997 after 106 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 Vil is a single chain molecule with a molecular weight of 45,000 - 50, 000 and is important for extrinsic coagulation. Factor VIl deficiency is commonly diagnosed in vitro through the used of a modified prothrombin time (PT) assay. When a patient sample is mixed with factor VI deficient plasma, the degree of correction of the PT is proportional to the level of Factor Vil in the patient plasma. CryoCheck Factor VI Deficient Plasma is human plasma deficient in the factor VIl coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VIl deficiencies in in vitro clot-based factor VIl assays using the one stage prothrombin time.

Source page: https://510kreport.com/device/K971224
Methodology: https://510kreport.com/methodology