# K063701: Teco Homocysteine Enzymatic Assay

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Apr 11, 2007 after 119 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Teco Enzymatic Homocysteine Assay is intended for in vitro quantitative determination of total homocysteine in serum and plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia.

Source page: https://510kreport.com/device/K063701
Methodology: https://510kreport.com/methodology