# K193204: Cryocheck Chromogenic Factor VIII

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Jul 17, 2020 after 240 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 K833892 (1984). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042576: Coatest SP Fviii, Instrumentation Laboratory CO (2004) Summary page 4.

## Most influential descendants
- K251440: CRYOcheck Chromogenic Factor VIII (2025), 0 descendants of its own

## Indications for use
CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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/K193204
Methodology: https://510kreport.com/methodology