# K050448: Chromopep PC, Chromopep at, Models 2.5 and 5

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Sep 23, 2005 after 213 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: 4 generations back to K915083 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023990: Chromocheck Protein C 25; Chromocheck Protein C 50, Precision Biologic (2003) Summary page 3.
- K023991: Chromocheck Antithrombin 25; Chromocheck Antithrombin 50, Precision Biologic (2003) Summary page 2.

## Indications for use
CHROMOPEP AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma. CHROMOPEP PC is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.

Source page: https://510kreport.com/device/K050448
Methodology: https://510kreport.com/methodology