Cleared Traditional

K002447 - MODIFICATION TO RAPID DRUG SCREEN 9-PANEL

K002447 is an FDA 510(k) clearance for MODIFICATION TO RAPID DRUG SCREEN 9-PANEL, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K002447 · American Bio Medica Corp. · Toxicology device
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Nov 2000
Decision
99d
Days
Class 2
Risk

K002447 is an FDA 510(k) clearance for the MODIFICATION TO RAPID DRUG SCREEN 9-PANEL. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Washington, US). The FDA issued a Cleared decision on November 16, 2000 after a review of 99 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 American Bio Medica Corp. devices

FDA 510(k) Submission Details - K002447

510(k) Number K002447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2000
Decision Date November 16, 2000
Days to Decision 99 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
12d slower than avg
Panel avg: 87d · This submission: 99d
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 158
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K002447.
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564 · Medtox Diagnostics, Inc. · Apr 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · Phamatech · Mar 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp. · Feb 2001
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395 · Alfa Scientific Designs, Inc. · Aug 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399 · Alfa Scientific Designs, Inc. · Aug 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · Roche Diagnostics Corp. · Jul 2000