# K980812: Imx Homocysteine

- Pathway: 510(k) (Traditional)
- Applicant: Axis Biochemicals, Asa
- Decided: Oct 1, 1998 after 212 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices 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

## Most influential descendants
- K984071: Liquichek Homocysteine Control, Cat #644 (1998), 15 descendants of its own
- K100715: Audit Microcv Homocysteine Linearity Set, Model 704M-5 (2010), 14 descendants of its own
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), 13 descendants of its own
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), 7 descendants of its own
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C (2014), 3 descendants of its own

## 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/K980812
Methodology: https://510kreport.com/methodology