Cleared Special

K031032 - VERDICT II, PROFILE II

K031032 is an FDA 510(k) clearance for VERDICT II, manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Special 510(k) pathway after a 104-day FDA review.

K031032 · Medtox Diagnostics, Inc. · Toxicology device
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Jul 2003
Decision
104d
Days
Class 2
Risk

K031032 is an FDA 510(k) clearance for the VERDICT II, PROFILE II. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on July 14, 2003 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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. Standard predicate reliance. 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 - K031032

510(k) Number K031032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2003
Decision Date July 14, 2003
Days to Decision 104 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
17d slower than avg
Panel avg: 87d · This submission: 104d
Pathway characteristics
Modification to existing cleared device.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K031032.
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K031002 · Beckman Coulter, Inc. · Apr 2003
AMEDICA DRUG SCREEN OPIATES TEST
K023047 · Amedica Biotech, Inc. · Nov 2002
K031032 · VERDICT II, PROFILE II
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