# DEB: Alpha-2-Macroglobulin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5620; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1977: 2
- 1979: 1
- 1981: 1
- 1985: 3
- 1989: 1
- 1991: 1
- 1998: 1
- 2006: 1
- 2008: 1
- 2014: 1

## Most-cited predicates
- K053073: N Antisera to Human ALPHA2-Macroglobulin (2006), cited by 1
- K791340: Human ALPHA2 Macroglobulin (1979), cited by 1

Source page: https://510kreport.com/product-code/DEB
Data by year (CSV): https://510kreport.com/product-code/DEB.csv