# DEM: Alpha-1-Antitrypsin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5130; FDA's rule: 510(k) required
- FDA decisions: 30
- Recalls: 1 (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)
- 1994: 1
- 1997: 6
- 1998: 1
- 1999: 1
- 2001: 2
- 2003: 1
- 2005: 2
- 2006: 1
- 2007: 1
- 2013: 1

## Most-cited predicates
- K053072: N Antisera to Human ALPHA1-Antitrypsin (2006), cited by 2
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii (2005), cited by 2
- K964766: Immage Immunochemistry System Alpha-1-Antitrypsin (Aat) (1997), cited by 1
- K972640: Tina-Quant Alpha Particle-1-Antitrypsin Assay (1998), cited by 1

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