Cleared Traditional

K100951 - MEDTOX BUPRENORPHINE TEST

K100951 is an FDA 510(k) clearance for MEDTOX BUPRENORPHINE TEST, manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code DJG cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K100951 · Medtox Diagnostics, Inc. · Chemistry device
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Oct 2010
Decision
195d
Days
Class 2
Risk

K100951 is an FDA 510(k) clearance for the MEDTOX BUPRENORPHINE TEST. 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 October 18, 2010 after a review of 195 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtox Diagnostics, Inc. devices

FDA 510(k) Submission Details - K100951

510(k) Number K100951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2010
Decision Date October 18, 2010
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 88d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Chemistry devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K100951.
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
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K093175 · Guangzhou Wondfo Biotech Co., Ltd. · Aug 2010
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K100051 · Alfa Scientific Designs, Inc. · Jul 2010
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
K101195 · Lin-Zhi International, Inc. · Jul 2010