# K072977: Diazyme Apolipoprotein a-1 Assay

- Pathway: 510(k) (Traditional)
- Applicant: General Atomics
- Decided: Jul 16, 2008 after 268 days
- Product code: MSJ (Apolipoproteins)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K993345 (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)
- K993345: K-Assay Apo AI, Kamiya Biomedical Co. (1999) Summary page 1.

## Indications for use
The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use. For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use. To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.

Source page: https://510kreport.com/device/K072977
Methodology: https://510kreport.com/methodology