Cleared Special

K012159 - RAPID DRUG SCREEN

K012159 is an FDA 510(k) clearance for RAPID DRUG SCREEN, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Special 510(k) pathway after a 33-day FDA review.

K012159 · American Bio Medica Corp. · Toxicology device
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Jul 2001
Decision
33d
Days
Class 2
Risk

K012159 is an FDA 510(k) clearance for the RAPID DRUG SCREEN. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Beverly, US). The FDA issued a Cleared decision on July 25, 2001 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all American Bio Medica Corp. devices

FDA 510(k) Submission Details - K012159

510(k) Number K012159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2001
Decision Date July 25, 2001
Days to Decision 33 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 87d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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
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