Cleared Traditional

K012484 - AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE

K012484 is an FDA 510(k) clearance for AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE, manufactured by Ameditech, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K012484 · Ameditech, Inc. · Toxicology device
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Nov 2001
Decision
120d
Days
Class 2
Risk

K012484 is an FDA 510(k) clearance for the AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Ameditech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 30, 2001 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Ameditech, Inc. devices

FDA 510(k) Submission Details - K012484

510(k) Number K012484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date November 30, 2001
Days to Decision 120 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
33d slower than avg
Panel avg: 87d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 185
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K012484.
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
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TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · Biosite Incorporated · Jun 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745 · Biosite Incorporated · Jan 2002
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp. · Nov 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · Microgenics Corp. · Aug 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · Syva Co. · Aug 2001