# K964767: Quantikine Ivd Beta-2-Microglobulin Enzyme Immunoassay (Eia (

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: May 29, 1997 after 183 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pharmacia’s B, Micro RIA: named in the summary without a submission number

## Indications for use
The Quantikine IVD β-microglobulin EIA kit is intended for the quantitative determination of β microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.

Source page: https://510kreport.com/device/K964767
Methodology: https://510kreport.com/methodology