Cleared Traditional

K012484 - AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE

K012484 is the FDA 510(k) clearance for AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE by Ameditech, Inc.. It is a Class 2 Toxicology device (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

Submission Details

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.

Device Classification

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 126
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)
K020395 · Lin-Zhi International, Inc. · Jun 2002
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