# K992274: Modification to Imx Homocysteine

- Pathway: 510(k) (Traditional)
- Applicant: Axis Biochemicals, Asa
- Decided: Oct 6, 1999 after 92 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) University of Bergen Homocysteine HPLC method: named in the summary without a submission number

## Indications for use
The IMx® Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the IMx Analyzer. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Source page: https://510kreport.com/device/K992274
Methodology: https://510kreport.com/methodology