# DJG: Enzyme Immunoassay, Opiates

- Device class: 2; regulation: 21 CFR 862.3650; FDA's rule: 510(k) required
- FDA decisions: 215
- 510(k) review time 2021–2025: median 150 days (middle half 82–399)
- 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)
- 2017: 4
- 2018: 5
- 2019: 3
- 2020: 5
- 2021: 3
- 2022: 2
- 2023: 10
- 2024: 5
- 2025: 3
- 2026: 3

## Most-cited predicates
- K142396: Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests (2014), cited by 8
- K040316: Cedia Buprenorphine Assay (2004), cited by 6
- K033047: Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test Device (2004), cited by 5
- K981341: STC Opiates Micro-Plate Eia (Orasure Application) (1998), cited by 5
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (2016), cited by 5
- K142280: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) (2014), cited by 4
- K060466: Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device (2006), cited by 4
- K143187: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (2015), cited by 4
- K001178: Cedia Dau 6-Acetylmorphine Assay (2000), cited by 4
- K220046: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 (2022), cited by 3

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