# K993107: Bio-Rad Homocysteine by HPLC

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 21, 1999 after 95 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 K980907 (1998). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K980907: Axis Homocysteine Enzyme Immunoassay, Axis Biochemicals, Asa (1998) Summary page 1.

## Most influential descendants
- K061588: Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers (2006), 1 descendant of its own
- K030754: A/C Enzymatic Homocysteine Assay (2003), 1 descendant of its own
- K123930: Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and Iii (2013), 0 descendants of its own
- K080851: A/C Portable Enzymatic Homocysteine Assay (2008), 0 descendants of its own

## Indications for use
The Bio-Rad Homocysteine by HPLC test is intended for the quantitative determination of total Homocysteine in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocysteinuria. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K993107
Methodology: https://510kreport.com/methodology