# K964766: Immage Immunochemistry System Alpha-1-Antitrypsin (Aat)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Apr 25, 1997 after 149 days
- Product code: DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5130
- 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 K771603 (1977). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771603: Immochemistry System, Beckman Instruments, Inc. (1977) Summary page 1.

## Most influential descendants
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii (2005), 3 descendants of its own
- K061588: Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers (2006), 1 descendant of its own
- K123930: Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and Iii (2013), 0 descendants of its own
- K060940: Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii (2006), 0 descendants of its own

## Indications for use
The IMMAGE Immunochemistry System Alpha-1-Antitrypsin (AAT) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human alpha-1-antitrypsin by rate nephelometry.

Source page: https://510kreport.com/device/K964766
Methodology: https://510kreport.com/methodology