# K122066: Human Beta-2 Microglobulin Urine Kit for Use on the Spaplus

- Pathway: 510(k) (Special)
- Applicant: The Binding Site Group, Ltd.
- Decided: Aug 30, 2012 after 45 days
- Product code: JZG (System, Test, Beta-2-Microglobulin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5630
- Recalls of this device: 1 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 9, 2018 · Class II · Z-1301-2018: The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.

## Indications for use
The kit is intended for the quantitative in vitro 'determination of beta-2 microglobulin (132M) in human urine using the SPAPLUS analyser, to aid the diagnosis of acive rheumatoid arthritis and kidney disease. The test result is to be used in conjunction with other clinical and laboratory findings

Source page: https://510kreport.com/device/K122066
Methodology: https://510kreport.com/methodology