# K061598: Hemosil Homocysteine and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 22, 2006 after 106 days
- Product code: LPS (Urinary Homocystine (Nonquantitative) Test System)
- Device class: 2
- Regulation: 21 CFR 862.1377
- 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 K992858 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992858: Abbott Axsym Homocysteine, Abbott Laboratories (1999) Summary page 1.

## Indications for use
HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems. Homocysteine (Hey) values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria. HemoslL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemoslL Homocysteine on IL Coagulation Systems.

Source page: https://510kreport.com/device/K061598
Methodology: https://510kreport.com/methodology