Cleared Special

K003687 - VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC

K003687 is an FDA 510(k) clearance for VERDICT II THC/COC/OPI/AMP, manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DKE cleared through the Special 510(k) pathway after a 22-day FDA review.

K003687 · Medtox Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
22d
Days
Class 2
Risk

K003687 is an FDA 510(k) clearance for the VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERD.... Classified as Reagents, Test, Tetrahydrocannabinol (product code DKE), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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.

FDA 510(k) Submission Details - K003687

510(k) Number K003687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2000
Decision Date December 22, 2000
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

DKE Device Classification - Class 2, Special Controls

Product Code DKE Reagents, Test, Tetrahydrocannabinol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - DKE Reagents, Test, Tetrahydrocannabinol

All 11
Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K003687.
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
K994405 · Alfa Scientific Designs, Inc. · Jun 2000
STATUS STIK, ACCUSIGN STIK
K992068 · Princeton BioMeditech Corp. · Jul 1999
STATUS CUP ACCUSIGN CUP
K991751 · Princeton BioMeditech Corp. · Jun 1999
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
K991078 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
K983147 · Princeton BioMeditech Corp. · Sep 1998
PROFILE-II MODEL 600582
K982211 · Medtox Diagnostics, Inc. · Jul 1998
K003687 · VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
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