# K214002: CRYOcheck Chromogenic Factor IX

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic, Inc.
- Decided: Dec 23, 2022 after 367 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 K893524 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031829: Hemosil Factor IX Deficient Plasma, Instrumentation Laboratory CO (2003) Summary page 4.

## Indications for use
CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K214002
Methodology: https://510kreport.com/methodology