Cleared Traditional

K934667 - METHADONE ENZYME IMMUNOASSAY

K934667 is an FDA 510(k) clearance for METHADONE ENZYME IMMUNOASSAY, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K934667 · Diagnostic Reagents, Inc. · Toxicology device
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Jan 1994
Decision
119d
Days
Class 2
Risk

K934667 is an FDA 510(k) clearance for the METHADONE ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K934667

510(k) Number K934667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date January 26, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 87d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJR Device Classification - Class 2, Special Controls

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 58
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K934667.
AXSYM METHADONE
K953499 · Abbott Laboratories · Nov 1995
AUTO-LYTE METHADONE DIA
K944056 · Solarcare Technologies Corp,Inc. · Dec 1994
CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST
K944074 · Beckman Instruments, Inc. · Dec 1994
DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK
K934147 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
K930928 · Roche Diagnostic Systems, Inc. · Sep 1993
METHADONE METABOLITE EIA ASSAY
K931780 · Diagnostic Reagents, Inc. · Aug 1993