# K112790: Axis-Shield 3-Reagent Homocysteine Assay for Synchron

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: May 7, 2012 after 224 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: 3 generations back to K011689 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083222: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100, Axis-Shield Diagnostics, Ltd. (2009) Summary page 1.

## Indications for use
The 3-Reagent Homocysteine Assay for Beckman Coulter SYNCHRON® and UniCel® systems is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemnia and homocysturia.

Source page: https://510kreport.com/device/K112790
Methodology: https://510kreport.com/methodology