# MVM: Autoantibodies, Endomysial (Tissue Transglutaminase)

- Device class: 2; regulation: 21 CFR 866.5660; FDA's rule: 510(k) required
- FDA decisions: 40
- 510(k) review time 2021–2025: median 558 days (middle half 549–566)
- 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)
- 2005: 2
- 2006: 4
- 2007: 2
- 2008: 3
- 2010: 2
- 2011: 3
- 2013: 2
- 2014: 1
- 2019: 2
- 2021: 2

## Most-cited predicates
- K011570: Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg Elisa (2001), cited by 3
- K011566: Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa (2001), cited by 3
- K041173: Celikey Igg Itg Igg Antibodies, Model 17996 (2004), cited by 2
- K042644: Aeskulisa TTG a and Aeskulisa TTG G (2005), cited by 2
- K062583: Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01 (2006), cited by 1
- K041174: Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196 (2004), cited by 1
- K094060: Quanta Flash H-TTG Iga (2010), cited by 1
- K010625: Eurospital EU-TTG Iga Umana (2001), cited by 1
- K102490: Igx Plex Celiac Qualitative Assay (2011), cited by 1
- K101644: Quanta Flash H-TTG Igg (2011), cited by 1

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