Cleared Traditional

K984525 - RAPID DRUG SCREEN 5-PANEL WITH METHAMPH...

K984525 is the FDA 510(k) clearance for RAPID DRUG SCREEN 5-PANEL WITH METHAMPH... by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K984525 · American Bio Medica Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
67d
Days
Class 2
Risk

K984525 is an FDA 510(k) clearance for the RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Hudson, US). The FDA issued a Cleared decision on February 26, 1999 after a review of 67 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bio Medica Corp. devices

Submission Details

510(k) Number K984525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1998
Decision Date February 26, 1999
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
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 97
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K984525.
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
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ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
K973075 · Roche Diagnostic Systems, Inc. · Oct 1997