# K931780: Methadone Metabolite Eia Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Aug 23, 1993 after 136 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023617: Dri Methadone Metabolite Enzyme Immunoassay (2003), 5 descendants of its own
- K151395: Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (2015), 3 descendants of its own
- K980746: Cedia Dau Eddp Assay (1998), 2 descendants of its own
- K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (2019), 1 descendant of its own
- K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls (2009), 1 descendant of its own

Source page: https://510kreport.com/device/K931780
Methodology: https://510kreport.com/methodology