CEDIA DAU Methadone Assay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K954227

Identifiers

510(k) Number: K954227 FDA 510(k)
FDA Product Code: DJR FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.3620 FDA 510(k)
Regulation Number: 862.3620 FDA 510(k)
Advisory Committee: Clinical Toxicology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The CEDIA DAU Methadone Assay is an enzyme immunoassay designed for the qualitative detection of methadone in biological specimens. It employs a competitive assay format to identify methadone presence, aiding in clinical toxicology evaluations, particularly in monitoring methadone maintenance treatment programs for potential opiate misuse.

This single-use, in vitro diagnostic device is intended for laboratory use and requires no special storage conditions beyond those specified in the manufacturer’s instructions. It is classified under FDA 510(k) clearance (K954227) and IVDD regulations, adhering to Class II device standards with special controls. The assay is supplied as a kit and must be handled in accordance with standard laboratory protocols for immunoassays.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CEDIA DAU METHADONE ASSAY (K954227) - FDA 510 (k), PDF K954227 CEDIA DAU METHADONE ASSAY - 510kdatabase.net, Detection of opiate use in a methadone maintenance treatment ..., cedia - methadone metabolite (eddp) assay application beckman ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K954227	Class II	Active

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Manufacturer

Manufacturer: Microgenics Corporation
FDA Applicant: Microgenics Corp.

Sources (2)

FDA 510(k) K954227 24 fields · synced Sep 20, 2026
EUDAMED 1 fields · synced Jun 1, 2026