# K072078: Quantia Beta-2 Microglobulin, Model: 302822307

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Dec 19, 2007 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 K943686 (1995). 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)
- K943686: IL Test Beta-2MICROGLOBULIN, Instrumentation Laboratory CO (1995) Summary page 1.

## Indications for use
The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (K050596) and the Beta-2 Microglobulin Standard (k050613).

Source page: https://510kreport.com/device/K072078
Methodology: https://510kreport.com/methodology