Cleared Special

K010564 - VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO

Also marketed or referenced as:
PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO

K010564 is an FDA 510(k) clearance for VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO..., manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Special 510(k) pathway after a 38-day FDA review.

K010564 · Medtox Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
38d
Days
Class 2
Risk

K010564 is an FDA 510(k) clearance for the VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 5, 2001 after a review of 38 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 Medtox Diagnostics, Inc. devices

FDA 510(k) Submission Details - K010564

510(k) Number K010564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date April 05, 2001
Days to Decision 38 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
49d faster than avg
Panel avg: 87d · This submission: 38d
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 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K010564.
RAPID DRUG SCREEN
K012159 · American Bio Medica Corp. · Jul 2001
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
K011499 · Sun Biomedical Laboratories, Inc. · Jul 2001
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177 · Sun Biomedical Laboratories, Inc. · May 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645 · Phamatech · Mar 2001
COBAS INTEGRA AMPHETAMINES
K003865 · Roche Diagnostics Corp. · Feb 2001
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
K002447 · American Bio Medica Corp. · Nov 2000