# K092048: One Step Eddp (Methadone Metabolite) Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Apr 19, 2010 after 286 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: 3 generations back to K931780 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012595: Acon MTD One Step Methadone Test Strip and Test Device, ACON Laboratories, Inc. (2001)
- K023617: Dri Methadone Metabolite Enzyme Immunoassay, Microgenics Corp. (2003) Summary page 2.
- K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls, Thermo Fisher Scientific (2009) Summary page 3.

## Indications for use
The One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic immunoassay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 nglmL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites. This assay provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K092048
Methodology: https://510kreport.com/methodology