# K013606: Acs 180 Homocysteine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Diagnostics Corp.
- Decided: Dec 21, 2001 after 51 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: 1 generation back to K992858 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992858: Abbott Axsym Homocysteine, Abbott Laboratories (1999) Summary page 1.

## Indications for use
Intended for in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ACS:180® System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.

Source page: https://510kreport.com/device/K013606
Methodology: https://510kreport.com/methodology