# K022195: Coamatic at-400

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Aug 7, 2002 after 33 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: 2 generations back to K915083 (1992). 2 ancestors in all.
2 later devices descend 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)
- K980499: IL Test Antithrombin, Instrumentation Laboratory CO (1998) Summary page 1.

## Most influential descendants
- K023991: Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 (2003), 1 descendant of its own
- K050448: Chromopep PC, Chromopep at, Models 2.5 and 5 (2005), 0 descendants of its own

## Indications for use
CoamaticB AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 10-125% of normal plasma.

Source page: https://510kreport.com/device/K022195
Methodology: https://510kreport.com/methodology