# MVO: Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 18
- 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)
- 1998: 1
- 1999: 5
- 2001: 8
- 2002: 2
- 2003: 1
- 2004: 1

## Most-cited predicates
- K003858: Modification to at Home Drug Test, Models 9150, 9068, and 9175 (2001), cited by 1
- K014192: Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met (2002), cited by 1
- K040327: Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine (THC, Coc) (2004), cited by 1

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