# K053073: N Antisera to Human ALPHA2-Macroglobulin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 28, 2006 after 147 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
Longest line of descent: 1 generation back to K860894 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860894: Behring Nephelometer System, Behring Diagnostics, Inc. (1986) Summary page 1.

## Most influential descendants
- K081249: Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem (2008), 0 descendants of its own

## Indications for use
In vitro diagnostic reagents for the quantitative determination of a 2-macroglobulin in human serum and heparinized plasma by means of immunonephelometery on the BNTM Systems. Measurement of a 2-macroglobulin may aid in the diagnosis of blood clotting or clot lysis disorders.

Source page: https://510kreport.com/device/K053073
Methodology: https://510kreport.com/methodology