# K994238: IL Test Liquid Antithrombin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jun 23, 2000 after 190 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.
4 later devices descend from it; 2 cite it directly.
0 of 7 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
- K033775: Hemosil Liquid Antithrombin XL (2004), 2 descendants of its own
- K062431: Hemosil Liquid Antithrombin (2006), 1 descendant of its own
- K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (2018), 0 descendants of its own
- K022550: Coamatic LR Antithrombin, Note: LR=Liquid Reagents (2002), 0 descendants of its own

## Indications for use
IL Test™ Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency. This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II. Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.

Source page: https://510kreport.com/device/K994238
Methodology: https://510kreport.com/methodology