# DJP: Radioimmunoassay, Amphetamine

- Device class: 2; regulation: 21 CFR 862.3100; FDA's rule: 510(k) required
- FDA decisions: 9
- 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)
- 1982: 2
- 1983: 1
- 1985: 1
- 1988: 2
- 1991: 2
- 1996: 1

## Most-cited predicates
- K960526: Primidone Eia Test (1996), cited by 1
- K881817: Abuscreen (R) Ontrak (TM) for Amphetamines (1988), cited by 1

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