# K980499: IL Test Antithrombin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 2, 1998 after 52 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: 1 generation back to K915083 (1992). 1 ancestor in all.
9 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915083: Coamate (R) Antithrombin Chromogenic Assay, Kabi Pharmacia, Inc. (1992) Summary page 1.

## Most influential descendants
- K994238: IL Test Liquid Antithrombin (2000), 4 descendants of its own
- K033775: Hemosil Liquid Antithrombin XL (2004), 2 descendants of its own
- K022195: Coamatic at-400 (2002), 2 descendants of its own
- K062431: Hemosil Liquid Antithrombin (2006), 1 descendant of its own
- K023991: Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 (2003), 1 descendant of its own

## Indications for use
IL Test™ Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

Source page: https://510kreport.com/device/K980499
Methodology: https://510kreport.com/methodology