Cleared Traditional

K972526 - METHADONE EIA ASSAY

K972526 is the FDA 510(k) clearance for METHADONE EIA ASSAY by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K972526 · Diagnostic Reagents, Inc. · Toxicology device
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Aug 1997
Decision
39d
Days
Class 2
Risk

K972526 is an FDA 510(k) clearance for the METHADONE EIA ASSAY. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 4, 1997 after a review of 39 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K972526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date August 04, 1997
Days to Decision 39 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
48d faster than avg
Panel avg: 87d · This submission: 39d
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 K972526.
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703 · Roche Diagnostic Systems, Inc. · Dec 1998
CEDIA DAU EDDP ASSAY
K980746 · Boehringer Mannheim Corp. · May 1998
SYNCHRON SYSTEMS METHADONE REAGENT
K973069 · Beckman Instruments, Inc. · Sep 1997
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
K962673 · Princeton BioMeditech Corp. · Aug 1996
CEDIA DAU METHADONE ASSAY
K954227 · Microgenics Corp. · Nov 1995
AXSYM METHADONE
K953499 · Abbott Laboratories · Nov 1995