# K971225: Cryo Check Factor Viii 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 trace protein which is present in vivo as a complex with von Willebrand factor and is necessary for intrinsic coagulation. Factor VIII deficiency (hemophilia A) is commonly diagnosed in vitro through the used of a modified activated partial thromboplastin time (APTT) assay. When a patient sample is mixed with factor VIII deficient plasma, the degree of correction of the APTT is proportional to the level of Factor Vil in the patient plasma. CryoCheck Factor VIII Deficient Plasma is human plasma deficient in the factor VIII coagulation protein while having all other coagulation factors within normal limits. It is indicated for use to assess factor VIII deficiencies in in vitro clot-based factor VIl assays using the activated partial thromboplastin time.

Source page: https://510kreport.com/device/K971225
Methodology: https://510kreport.com/methodology