# K011692: Homogeneous Enzymic Homocysteine Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Intersect Systems, Inc.
- Decided: Jul 25, 2001 after 55 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.
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.

## Recalls of this device
- Jan 18, 2007 · Not classified · Z-0448-2009: A high homocysteine level can be reported as falsely low.

## Indications for use
A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

Source page: https://510kreport.com/device/K011692
Methodology: https://510kreport.com/methodology