# K062808: Liquid Stable (LS) 2-Part Homocysteine Reagent

- Pathway: 510(k) (Special)
- Applicant: Catch Incorporated
- Decided: Oct 13, 2006 after 24 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 K011689 (2001). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011689: Homogeneous Enzymic Homocysteine Reagent, Catch, Inc. (2001) Summary page 2.

## Most influential descendants
- K083222: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 (2009), 1 descendant of its own
- K112790: Axis-Shield 3-Reagent Homocysteine Assay for Synchron (2012), 0 descendants of its own

## Indications for use
Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.

Source page: https://510kreport.com/device/K062808
Methodology: https://510kreport.com/methodology