Cleared Traditional

K934147 - DUPONT ACA METHADONE (UMETH) SCREEN TES...

K934147 is the FDA 510(k) clearance for DUPONT ACA METHADONE (UMETH) SCREEN TES... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K934147 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Nov 1993
Decision
76d
Days
Class 2
Risk

K934147 is an FDA 510(k) clearance for the DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on November 9, 1993 after a review of 76 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K934147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date November 09, 1993
Days to Decision 76 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
11d faster than avg
Panel avg: 87d · This submission: 76d
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 K934147.
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
ROCHE ABUSCREEN ONLINE FOR METHADONE
K930928 · Roche Diagnostic Systems, Inc. · Sep 1993
METHADONE METABOLITE EIA ASSAY
K931780 · Diagnostic Reagents, Inc. · Aug 1993
IL TEST METHADONE
K920858 · Instrumentation Laboratory CO · Apr 1992