# DIC: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

- Device class: 2; regulation: 21 CFR 862.3040; FDA's rule: 510(k) required
- FDA decisions: 33
- 510(k) review time 2021–2025: median 199 days (middle half 199–199)
- Recalls: 3 (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)
- 2002: 1
- 2003: 1
- 2006: 1
- 2007: 2
- 2010: 2
- 2011: 2
- 2012: 1
- 2013: 1
- 2018: 1
- 2025: 1

## Most-cited predicates
- K904302: Dupont Dimension (R) Ethyl Alcohol (Alc) Method (1990), cited by 3
- K093879: Mission Saliva Alcohol Test Strip (2010), cited by 2
- K894001: Saliva Alcohol Test (1990), cited by 2
- K010960: Emit II Plus Ethyl Alcohol Assay, Model OSR9K229 (2001), cited by 2
- K871645: TDXR Rea (TM) Ethanol (1987), cited by 1
- K121256: Alco-Screen 02 (2012), cited by 1
- K032461: Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221 (2003), cited by 1
- K903153: Emit Ethyl Alcohol Assay (1990), cited by 1

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