# K992858: Abbott Axsym Homocysteine

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 25, 1999 after 61 days
- Product code: LPS (Urinary Homocystine (Nonquantitative) Test System)
- Device class: 2
- Regulation: 21 CFR 862.1377
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 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) Abbott IMx® Homocysteine assay: named in the summary without a submission number

## Most influential descendants
- K052788: N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H (2006), 4 descendants of its own
- K063206: Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High (2006), 1 descendant of its own
- K110874: Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator (2012), 0 descendants of its own
- K083463: Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control M (2009), 0 descendants of its own
- K073640: Architect Homocysteine Reagents, Calibrators and Controls (2008), 0 descendants of its own

## Recalls of this device
- Aug 22, 2003 · Not classified · Z-1218-03: There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.

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

Source page: https://510kreport.com/device/K992858
Methodology: https://510kreport.com/methodology