# K183440: CRYOcheck FVIII Inhibitor Kit

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic, Inc.
- Decided: Mar 12, 2019 after 90 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- 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: 2 generations back to K993553 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082205: Factor Viii Antibody Screen, Genetic Testing Institute (2008) Summary page 4.

## Indications for use
The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a Factor VIII activity assay to enable the performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years or older. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K183440
Methodology: https://510kreport.com/methodology