Cleared Traditional

K964900 - RAPID DRUG SCREEN

K964900 is the FDA 510(k) clearance for RAPID DRUG SCREEN by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K964900 · American Bio Medica Corp. · Toxicology device
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Apr 1997
Decision
138d
Days
Class 2
Risk

K964900 is an FDA 510(k) clearance for the RAPID DRUG SCREEN. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Ancramdale, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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

Submission Details

510(k) Number K964900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date April 14, 1997
Days to Decision 138 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
51d slower than avg
Panel avg: 87d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 65
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K964900.
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K963918 · Diagnostic Products Corp. · Apr 1997
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K962353 · Princeton BioMeditech Corp. · Aug 1996
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K960187 · Diagnostic Reagents, Inc. · Apr 1996