# K222831: CRYOcheck Factor VIII Deficient Plasma with VWF

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic, Inc.
- Decided: Sep 13, 2023 after 359 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: 3 generations back to K893525 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110237: Hemosil Factor Viii Deficient Plasma, Instrumentation Laboratory CO (2011) Summary page 4.

## Indications for use
CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use

Source page: https://510kreport.com/device/K222831
Methodology: https://510kreport.com/methodology