# K061296: Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine Calibrator

- Pathway: 510(k) (Special)
- Applicant: Diazyme Laboratories
- Decided: Jun 13, 2006 after 35 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K113793: Homocysteine Test (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K061296
Methodology: https://510kreport.com/methodology