# K073640: Architect Homocysteine Reagents, Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Apr 24, 2008 after 120 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
The ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT i System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of total L-homocysteine in human serum or plasma. The ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument), when used for the quantitative determination of total L-homocysteine in human serum or plasma.

Source page: https://510kreport.com/device/K073640
Methodology: https://510kreport.com/methodology