# MST: Antibodies, Gliadin

- Device class: 2; regulation: 21 CFR 866.5750; FDA's rule: 510(k) required
- FDA decisions: 42
- 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)
- 2005: 2
- 2006: 4
- 2007: 2
- 2008: 1
- 2009: 2
- 2010: 2
- 2011: 1
- 2012: 2
- 2013: 1
- 2017: 1

## Most-cited predicates
- K052142: Quanta Lite Gliadin Igg II (2005), cited by 4
- K052143: Quanta Lite Gliadin Iga II (2005), cited by 4
- K113863: Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg Calibrators (2012), cited by 2
- K041357: Varelisa Gliadin Igg Antibodies (2004), cited by 2
- K964986: Quanta Lite Iga Gliadin Elisa (1997), cited by 1
- K981929: Bindazyme Antigliadin Igg/Iga Combi Kit (1998), cited by 1
- K041354: Varelisa Gliadin Iga Antibodies Model #19848/19896 (2004), cited by 1
- K093459: Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01, 14-5539-01 (2010), cited by 1
- K982533: Unicap Gliadin Iga Assay (1998), cited by 1
- K052439: Aeskulisa Glia a and Aeskulisa Glia G (2006), cited by 1

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