# K140664: Human ALPHA2-Macroglobulin Kit for Use on Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Apr 16, 2014 after 29 days
- Product code: DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5620
- 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 quantitative in vitro measurement of alpha-2-Macroglobulin in human serum using the SPAPLUS turbidimetric analyser. Measurement of alpha 2-Macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders. This test should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K140664
Methodology: https://510kreport.com/methodology