# DJR: Enzyme Immunoassay, Methadone

- Device class: 2; regulation: 21 CFR 862.3620; FDA's rule: 510(k) required
- FDA decisions: 63
- Recalls: 6 (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)
- 2004: 1
- 2006: 4
- 2009: 1
- 2010: 3
- 2013: 1
- 2015: 3
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 1

## Most-cited predicates
- K931780: Methadone Metabolite Eia Assay (1993), cited by 3
- K021505: Online Dat II Methadone II (2002), cited by 3
- K051058: Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls (2006), cited by 2
- K023617: Dri Methadone Metabolite Enzyme Immunoassay (2003), cited by 2
- K023317: Methadone Enzyme Immunoassay (2002), cited by 2
- K012595: Acon MTD One Step Methadone Test Strip and Test Device (2001), cited by 2
- K151395: Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (2015), cited by 2
- K002010: STC Methadone Intercept Micro-Plate Eia, Model 11421 (2000), cited by 1
- K023869: 'Rapidtec'-5M-Multiple Dip Test (2003), cited by 1
- K930928: Roche Abuscreen Online for Methadone (1993), cited by 1

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