# K033775: Hemosil Liquid Antithrombin XL

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Jan 2, 2004 after 30 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.
2 later devices descend from it; 1 cites it directly.
0 of 6 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.
- K994238: IL Test Liquid Antithrombin, Instrumentation Laboratory CO (2000) Summary page 1.

## Most influential descendants
- 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

## Indications for use
HemosiL Liquid Antithrombin XL is a modified version of HemoslL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400). This modification does not alter the fundamental scientific technology of the device or its intended use as 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 and to monitor Antithrombin substitution therapy.

Source page: https://510kreport.com/device/K033775
Methodology: https://510kreport.com/methodology