# NGL: Test, Opiates, Over The Counter

- Device class: 2; regulation: 21 CFR 862.3650; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 38 days (middle half 30–54)
- 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)
- 2008: 1
- 2010: 1
- 2018: 1
- 2019: 1
- 2020: 1
- 2023: 1
- 2024: 13
- 2025: 4

## Most-cited predicates
- K233417: AllTest Fentanyl Urine Test Cassette (2023), cited by 8
- K240686: Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (2024), cited by 3
- K241969: Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (2024), cited by 1
- K082898: Amedica Drug Screen Test Cup (2008), cited by 1

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