# K050613: Quantia Beta-2 Microglobulin

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Aug 16, 2005 after 159 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-microglubulin concentration in human serum or plasma (EDTA) on the AEROSET ® instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. Quantia PROTEINS Control is intended for use in monitoring the quality control of results obtained with the Quantia Beta-2 Microglobulin and Quantia Al-AT reagents by turbidimetry. (NOTE: This control has been also 510(k) FDA submitted for use with Al-AT) For in vitro diagnostic use Quantia Beta-2 Microglobulin Standard is intended for use in establishing the calibration curve for the Quantia Beta-2 Microglobulin reagents by turbidimetry. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K050613
Methodology: https://510kreport.com/methodology