# K070301: Hemosil Antithrombin

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Feb 23, 2007 after 23 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
HemosLiL 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/K070301
Methodology: https://510kreport.com/methodology