# K014270: Minineph Human B2-Microglobulin Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Aug 15, 2002 after 231 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Source page: https://510kreport.com/device/K014270
Methodology: https://510kreport.com/methodology