Cleared Traditional

K973986 - MECTEST

K973986 is the FDA 510(k) clearance for MECTEST by Meco Industries. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K973986 · Meco Industries · Toxicology device
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Apr 1998
Decision
186d
Days
Class 2
Risk

K973986 is an FDA 510(k) clearance for the MECTEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Meco Industries (Walnut, US). The FDA issued a Cleared decision on April 24, 1998 after a review of 186 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 Meco Industries devices

Submission Details

510(k) Number K973986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1997
Decision Date April 24, 1998
Days to Decision 186 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 87d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K973986.
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MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
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ONTRAK TESTCUP-ER
K983388 · Roche Diagnostic Systems, Inc. · Nov 1998
IMMULITE COCAINE METABOLITE
K963918 · Diagnostic Products Corp. · Apr 1997
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
K962353 · Princeton BioMeditech Corp. · Aug 1996
COCAINE METABOLITE EIA TEST
K960187 · Diagnostic Reagents, Inc. · Apr 1996