Cleared Traditional

K010496 - CEDIA DAU AMPHETAMINES/ECSTASY ASSAY

K010496 is an FDA 510(k) clearance for CEDIA DAU AMPHETAMINES/ECSTASY ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with product code LAF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K010496 · Microgenics Corp. · Toxicology device
Download Printable Device Report (PDF)
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May 2001
Decision
97d
Days
Class 2
Risk

K010496 is an FDA 510(k) clearance for the CEDIA DAU AMPHETAMINES/ECSTASY ASSAY. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 29, 2001 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 Microgenics Corp. devices

FDA 510(k) Submission Details - K010496

510(k) Number K010496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2001
Decision Date May 29, 2001
Days to Decision 97 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
10d slower than avg
Panel avg: 87d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAF Device Classification - Class 2, Special Controls

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 39
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K010496.
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
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K003847 · Alfa Scientific Designs, Inc. · May 2001
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · Phamatech · Apr 2001
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K993852 · Worldwide Medical Corp. · Nov 2000
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K000096 · Roche Diagnostics Corp. · Apr 2000