# DKZ: Enzyme Immunoassay, Amphetamine

- Device class: 2; regulation: 21 CFR 862.3100; FDA's rule: 510(k) required
- FDA decisions: 225
- 510(k) review time 2021–2025: median 82 days (middle half 55–158)
- Recalls: 18 (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: 8
- 2014: 8
- 2015: 5
- 2016: 5
- 2018: 3
- 2019: 3
- 2020: 1
- 2023: 2
- 2024: 1

## Most-cited predicates
- K052115: First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy (2005), cited by 13
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), cited by 12
- K061718: Innovacon Spectrum II Test Card (2006), cited by 7
- K020313: Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test Device (2002), cited by 4
- K011673: Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test Device (2001), cited by 4
- K091588: Ucp Home Drug Screening Tests (2009), cited by 4
- K992918: STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103I (2000), cited by 4
- K933052: Abuscreen Online (R) for Amphetamines, Modified (1993), cited by 3
- K043028: Emit II Plus Ecstasy Assay (2005), cited by 3
- K012110: Dri Ecstasy Enzyme Immunoassay (2001), cited by 3

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