Cleared Traditional

K003708 - ADVANTAGE THC/COCAINE TEST

K003708 is the FDA 510(k) clearance for ADVANTAGE THC/COCAINE TEST by Advantage Diagnostics Corp.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K003708 · Advantage Diagnostics Corp. · Toxicology device
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Jan 2001
Decision
52d
Days
Class 2
Risk

K003708 is an FDA 510(k) clearance for the ADVANTAGE THC/COCAINE TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Advantage Diagnostics Corp. (Redwood City, US). The FDA issued a Cleared decision on January 22, 2001 after a review of 52 days - a notably fast clearance 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: 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 Advantage Diagnostics Corp. devices

Submission Details

510(k) Number K003708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2000
Decision Date January 22, 2001
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
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 K003708.
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AT WORK DRUG TEST, MODEL 9177T AWT
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K010650 · Phamatech · Mar 2001
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K994403 · Alfa Scientific Designs, Inc. · Aug 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · Alfa Scientific Designs, Inc. · Jul 2000
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · Dade Behring, Inc. · Apr 2000