# K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Jan 14, 2009 after 243 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: 2 generations back to K931780 (1993). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K980746: Cedia Dau Eddp Assay, Boehringer Mannheim Corp. (1998) Summary page 2.
- K980853: Cedia Dau Multi-Drug Calibrators, Boehringer Mannheim Corp. (1998) Summary page 2.
- K040758: MGC Dau Control Sets: Primary, Clinical and Select, Microgenics Corp. (2004) Summary page 2.

## Most influential descendants
- K092048: One Step Eddp (Methadone Metabolite) Test Strip (2010), 0 descendants of its own

## Indications for use
The DRI Methadone Metabolite (1001300) Assay is intended for the qualitative and semi-quantitative determination of the presence of Methadone Metabolite (2-ethylidene-1,,5-dimethyl-3,3-diphenylpyrrolidine or EDDP) in human urine at cutoffs of 100 and 300 ng/mL. The DRI Methadone Metabolite Calibrators are intended for use in calibration of the DRI Methadone Metabolite (100/300) Assay. The DRI Methadone Metabolite Controls are intended for use in the DRI Methadone Metabolite (100/300) Assay to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. Tests for-methadone metabolite cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methadone metabolite and cause false positive results.

Source page: https://510kreport.com/device/K081378
Methodology: https://510kreport.com/methodology