# K980907: Axis Homocysteine Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Axis Biochemicals, Asa
- Decided: Oct 16, 1998 after 220 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.
22 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K920093: Audiotone Model a-96, Miracle-Ear, Inc. (1992). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
- K993107: Bio-Rad Homocysteine by HPLC (1999), 4 descendants of its own

## Indications for use
The Axis Homocysteine Enzyme Immunoassay is intended for the quantitative measurement 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 homocysteinuria.

Source page: https://510kreport.com/device/K980907
Methodology: https://510kreport.com/methodology