Cleared Traditional

K954227 - CEDIA DAU METHADONE ASSAY

K954227 is the FDA 510(k) clearance for CEDIA DAU METHADONE ASSAY by Microgenics Corp.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K954227 · Microgenics Corp. · Toxicology device
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Nov 1995
Decision
67d
Days
Class 2
Risk

K954227 is an FDA 510(k) clearance for the CEDIA DAU METHADONE ASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on November 17, 1995 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microgenics Corp. devices

Submission Details

510(k) Number K954227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date November 17, 1995
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DJR Enzyme Immunoassay, Methadone

All 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K954227.
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · Beckman Instruments, Inc. · Sep 1997
METHADONE EIA ASSAY
K972526 · Diagnostic Reagents, Inc. · Aug 1997
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
K962673 · Princeton BioMeditech Corp. · Aug 1996
AXSYM METHADONE
K953499 · Abbott Laboratories · Nov 1995
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074 · Beckman Instruments, Inc. · Dec 1994
METHADONE ENZYME IMMUNOASSAY
K934667 · Diagnostic Reagents, Inc. · Jan 1994