# K030754: A/C Enzymatic Homocysteine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Anticancer, Inc.
- Decided: Jul 11, 2003 after 123 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
Longest line of descent: 2 generations back to K980907 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993107: Bio-Rad Homocysteine by HPLC, Bio-Rad (1999) Summary page 1.

## Most influential descendants
- K080851: A/C Portable Enzymatic Homocysteine Assay (2008), 0 descendants of its own

## Indications for use
The A/C Enzymatic Homocysteine Assay is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The A/C Enzymatic Homocysteine Assay is only for in vitro diagnostic use.

Source page: https://510kreport.com/device/K030754
Methodology: https://510kreport.com/methodology