# K073488: Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Mar 7, 2008 after 137 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 K993354 (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)
- K993354: K-Assay Apo B, Kamiya Biomedical Co. (1999) Summary page 2.

## Indications for use
The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) 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 B Assay in serum. For in vitro Diagnostic Use. To monitor the performance of Diazyme Apolipoprotein B Assay in serum. For in vitro Diagnostic Use.

Source page: https://510kreport.com/device/K073488
Methodology: https://510kreport.com/methodology