# NFT: Test, Amphetamine, Over The Counter

- Device class: 2; regulation: 21 CFR 862.3100; FDA's rule: 510(k) required
- FDA decisions: 32
- 510(k) review time 2021–2025: median 40 days (middle half 30–59)
- 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)
- 2017: 1
- 2018: 6
- 2019: 1
- 2020: 2
- 2021: 1
- 2022: 3
- 2023: 1
- 2024: 4
- 2025: 8
- 2026: 5

## Most-cited predicates
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), cited by 7
- K202567: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx (2020), cited by 3
- K182530: BIOEASY Multi-Drug Test Cup (2018), cited by 3
- K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (2025), cited by 3
- K241428: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (2024), cited by 2
- K181768: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (2018), cited by 2
- K222667: Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx (2022), cited by 1
- K233062: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (2023), cited by 1
- K180349: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (2018), cited by 1
- K191841: Accurate Multi Panel Drug Urine Test Cup (2019), cited by 1

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