# K071971: Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model (S) Dzxxxa, Dzxxxa-Cal

- Pathway: 510(k) (Special)
- Applicant: Diazyme Laboratories
- Decided: Sep 17, 2007 after 62 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K121053: Diazyme Homocysteine Poc Test Kit (2012), 0 descendants of its own
- K113793: Homocysteine Test (2012), 0 descendants of its own

## Indications for use
Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrous oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism. Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.

Source page: https://510kreport.com/device/K071971
Methodology: https://510kreport.com/methodology