Cleared Special

K010959 - VERDICT -II BAR

Also marketed or referenced as:
VERDICT -II BZO

K010959 is an FDA 510(k) clearance for VERDICT -II BAR, manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Special 510(k) pathway after a 14-day FDA review.

K010959 · Medtox Diagnostics, Inc. · Toxicology device
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Apr 2001
Decision
14d
Days
Class 2
Risk

K010959 is an FDA 510(k) clearance for the VERDICT -II BAR. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 13, 2001 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 - K010959

510(k) Number K010959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2001
Decision Date April 13, 2001
Days to Decision 14 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
73d faster than avg
Panel avg: 87d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K010959.
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
K003647 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
K010125 · Alfa Scientific Designs, Inc. · May 2001
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
K010934 · Syva Co., Dade Behring, Inc. · Apr 2001
VERDICT -II BAR/BZO
K010561 · Medtox Diagnostics, Inc. · Apr 2001
PROFILE-ER
K002331 · Medtox Diagnostics, Inc. · Jan 2001
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · OraSure Technologies, Inc. · Dec 2000