# K993354: K-Assay Apo B

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Oct 28, 1999 after 23 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073488: Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx (2008), 0 descendants of its own

## Indications for use
The K-ASSAY Apo B Assay is intended to be used for the quantitative determination of Apo B 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 disorders. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K993354
Methodology: https://510kreport.com/methodology