# DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

- Device class: 2; regulation: 21 CFR 862.3250; FDA's rule: 510(k) required
- FDA decisions: 145
- 510(k) review time 2021–2025: median 106 days (middle half 98–113)
- Recalls: 8 (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)
- 2012: 5
- 2013: 2
- 2014: 2
- 2015: 2
- 2016: 3
- 2017: 3
- 2018: 1
- 2020: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K020771: Acon One Step Drug Screen Test Card (2002), cited by 9
- K010841: Acon Coc One Step Cocaine Test Strip, Acon Coc One Step Cocaine Test Device (2001), cited by 6
- K141647: Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card) (2014), cited by 4
- K020763: Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit) (2002), cited by 3
- K001197: Cocaine Metabolite Intercept Micro-Plate Eia (2000), cited by 3
- K023626: Aml Haircheck-DT (Cocaine) (2003), cited by 2
- K112071: Wondfo Cocaine Urine Test Model W10-CU, W10-P, Wondfo Methamphetamine Urine Test Model W11-CU, W11-P (2011), cited by 2
- K031512: Emit II Plus Cocaine Metabolite Assay (2003), cited by 2
- K960187: Cocaine Metabolite Eia Test (1996), cited by 2
- K990822: Rapidone - Cocaine Test (1999), cited by 2

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