# K050365: Biophen Protein C5, C2.5, Models 221205, 221202

- Pathway: 510(k) (Traditional)
- Applicant: Hyphen Biomed
- Decided: Dec 27, 2005 after 316 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922201 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922201: Coamate Protein C Chromogenic Assay, Chromogenix AB (1992) Summary page 1.

## Recalls of this device
- Feb 1, 2023 · Class II · Z-1227-2023: New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become haza

## Indications for use
Biophen Protein C 5 &2.5 kit is a Chromogenic assay for measuring the Protein C Activity in human citrated plasma using a manual or an automated method.

Source page: https://510kreport.com/device/K050365
Methodology: https://510kreport.com/methodology