# K032692: Dakocytomation Beta-2-Microglobulin Kit, Code NO. OA 368

- Pathway: 510(k) (Traditional)
- Applicant: Dako A/S
- Decided: Jan 22, 2004 after 142 days
- Product code: JZG (System, Test, Beta-2-Microglobulin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5630
- 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 K890421 (1989). 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)
- K890421: Imx B2-Microglobulin, Abbott Laboratories (1989) Summary page 2.

## Indications for use
For in vitro diagnostic use. DakoCytomation Beta-2-Microglobulin Kit is intended for the quantitative determination of beta-2-microglobulin in human serum and plasma by rate nephelometry on IMMAGE ® Immunochemistry Systems. Measurement of beta-2-microglobulin aids in the diagnosis of patients with active rheumatoid arthritis and kidney disease.

Source page: https://510kreport.com/device/K032692
Methodology: https://510kreport.com/methodology