# PJD: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device

- Device class: 2; regulation: 21 CFR 862.1675; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 144 days (middle half 104–184)
- 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)
- 1995: 1
- 1997: 1
- 1998: 1
- 1999: 1
- 2001: 1
- 2019: 1
- 2020: 1
- 2023: 2

## Most-cited predicates
- K970357: Episcreen (1997), cited by 3
- K942435: Saliva Sampler (1995), cited by 2
- K183048: Quantisal II Oral Fluid Collection Device (2019), cited by 2
- K984361: Oral-Eze Oral Fluid Collection System (1999), cited by 1
- K973395: Episcreen Oral Specimen Collection Device (1998), cited by 1
- K200801: Quantisal Oral Fluid Collection Device (2020), cited by 1

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