# K974564: Immage Immunochemistry System Alpha-2-Macroglobulin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Feb 17, 1998 after 74 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. The FDA summary names its predicate without a number.
- (no number) Beckman Array System AMG Reagent: named in the summary without a submission number

## Indications for use
The IMMAGE Immunochemistry System Alpha₂-Macroglobulin (AMG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha₂-macroglobulin by rate nephelometry.

Source page: https://510kreport.com/device/K974564
Methodology: https://510kreport.com/methodology