# K993345: K-Assay Apo AI

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Oct 25, 1999 after 20 days
- Product code: DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K072977: Diazyme Apolipoprotein a-1 Assay (2008), 0 descendants of its own

## Indications for use
The K-ASSAY Apo Al Assay is intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K993345
Methodology: https://510kreport.com/methodology