# K080851: A/C Portable Enzymatic Homocysteine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Anticancer, Inc.
- Decided: Oct 10, 2008 after 198 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: 3 generations back to K980907 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030754: A/C Enzymatic Homocysteine Assay, Anticancer, Inc. (2003) Summary page 1.

## Indications for use
The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) 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 for in vitro diagnostic use.

Source page: https://510kreport.com/device/K080851
Methodology: https://510kreport.com/methodology