# K083222: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Jul 31, 2009 after 270 days
- Product code: LPS (Urinary Homocystine (Nonquantitative) Test System)
- Device class: 2
- Regulation: 21 CFR 862.1377
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011689 (2001). 2 ancestors in all.
1 later device descends 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)
- K062808: Liquid Stable (LS) 2-Part Homocysteine Reagent, Catch Incorporated (2006) Summary page 1.

## Most influential descendants
- K112790: Axis-Shield 3-Reagent Homocysteine Assay for Synchron (2012), 0 descendants of its own

## Recalls of this device
- Sep 16, 2019 · Class II · Z-0742-2020: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Sep 16, 2019 · Class II · Z-0743-2020: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Sep 16, 2019 · Class II · Z-0744-2020: There is a potential performance issue as detected by an under-recovery of sample results during routine testing.
- Apr 3, 2015 · Class II · Z-2063-2016: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows dete
- Mar 20, 2015 · Class II · Z-1946-2015: Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.

## Indications for use
The Liquid Stable (LS) 2-Part Homocysteine Reagent 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 hyperhomocysteinemia and homocystinuria.

Source page: https://510kreport.com/device/K083222
Methodology: https://510kreport.com/methodology