# K023617: Dri Methadone Metabolite Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Aug 27, 2003 after 302 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
Longest line of descent: 1 generation back to K931780 (1993). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931780: Methadone Metabolite Eia Assay, Diagnostic Reagents, Inc. (1993) Summary page 1.

## Most influential descendants
- K151395: Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets (2015), 3 descendants of its own
- K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (2019), 1 descendant of its own
- K200363: Quidel Triage® TOX Drug Screen, 94600 (2020), 0 descendants of its own
- K182779: ARK EDDP Assay (2018), 0 descendants of its own
- K092048: One Step Eddp (Methadone Metabolite) Test Strip (2010), 0 descendants of its own

## Indications for use
The Methadone Metabolite Immunoassay is intended to be used for the qualitative and semiquantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 300 and 1000 ng/mL. The semiquantitative range of the assay is 31-2000 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect methadone metabolite in human urine.

Source page: https://510kreport.com/device/K023617
Methodology: https://510kreport.com/methodology