# K964257: Immage Immunochemistry System Alpha-1-Acid Glycoprotein (Aag) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Mar 24, 1997 after 150 days
- Product code: LKL (Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5420
- 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 K791341 (1979). 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)
- K791341: Human Alpha, Acid Glycoprotein, Beckman Instruments, Inc. (1979) Summary page 1.

## Indications for use
The IMMAGE Immunochemistry System Alpha-1-Acid Glycoprotein (AAG) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human alpha-1-acid glycoprotein by rate nephelometry.

Source page: https://510kreport.com/device/K964257
Methodology: https://510kreport.com/methodology