# JXO: Enzyme Immunoassay, Cocaine

- Device class: 2; regulation: 21 CFR 862.3250; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 414 days (middle half 414–414)
- 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)
- 1991: 1
- 1992: 3
- 2012: 1
- 2021: 1

## Most-cited predicates
- K111925: Psychemedics Cocaine Eia (2012), cited by 1

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