# LDJ: Enzyme Immunoassay, Cannabinoids

- Device class: 2; regulation: 21 CFR 862.3870; FDA's rule: 510(k) required
- FDA decisions: 151
- 510(k) review time 2021–2025: median 135 days (middle half 134–148)
- Recalls: 5 (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)
- 2009: 1
- 2011: 4
- 2012: 4
- 2013: 3
- 2014: 2
- 2015: 3
- 2016: 1
- 2019: 1
- 2023: 1
- 2024: 2

## Most-cited predicates
- K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine) (2001), cited by 6
- K140546: Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test (2014), cited by 4
- K963654: Quikstrip Onestep Marijuana (THC) Test (1997), cited by 2
- K002375: STC Cannabinoids Intercept Micro-Plate Eia, Model 1118I (2001), cited by 2
- K110239: Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, Control (2011), cited by 2
- K943998: Cannabinoid Eia Assay (1994), cited by 2
- K993984: Syva Emit II Plus Cannabinoid Assay, Models 9N029UL/9N129UL (2000), cited by 1
- K990818: Rapidone - Marijuana Test (1999), cited by 1
- K111929: Psychemedics Cannabinoids Eia (2012), cited by 1
- K021887: Cannabinoid Enzyme Immunoassay, Catalog 0070, 0071 (2002), cited by 1

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