# K161297: Beta-2-Microglobulin

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter Ireland, Inc.
- Decided: Jun 7, 2016 after 29 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 K991136 (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)
- K991136: B-2-Microglobulin Immunological Test System, Olympus America, Inc. (1999) Summary page 4.

## Indications for use
System reagent for the quantitative determination of β-2-Microglobulin (β2M) in human serum on Beckman Coulter AU analyzers

Source page: https://510kreport.com/device/K161297
Methodology: https://510kreport.com/methodology