# K023991: Chromocheck Antithrombin 25; Chromocheck Antithrombin 50

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic
- Decided: Apr 28, 2003 after 146 days
- Product code: JBQ (Antithrombin Iii Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915083 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022195: Coamatic at-400, Instrumentation Laboratory CO (2002)

## Most influential descendants
- K050448: Chromopep PC, Chromopep at, Models 2.5 and 5 (2005), 0 descendants of its own

## Indications for use
ChromoCheckTMAntithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

Source page: https://510kreport.com/device/K023991
Methodology: https://510kreport.com/methodology