# K032012: Homocysteine Microtiter Plate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Sep 3, 2003 after 65 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.
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)
- K980907: Axis Homocysteine Enzyme Immunoassay, Axis Biochemicals, Asa (1998) Summary page 1.

## Indications for use
The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Source page: https://510kreport.com/device/K032012
Methodology: https://510kreport.com/methodology