# K965033: Immage Immunochemistry System Alpha-1-Microglobulin (AI) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Apr 21, 1997 after 125 days
- Product code: MGA (Alpha-1 Microglobulin, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5400
- 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 K933078 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933078: Beckman Alpha-1-Microglobulin (A1M) Reagent, Beckman Instruments, Inc. (1994) Summary page 1.

## Indications for use
The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of of alpha-1-microglobulin in urine by rate nephelometry.

Source page: https://510kreport.com/device/K965033
Methodology: https://510kreport.com/methodology