# K791340: Human ALPHA2 Macroglobulin

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Aug 16, 1979 after 31 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.
5 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973932: Beckman Calibrator 2 (CAL2) (1997), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K791340
Methodology: https://510kreport.com/methodology