Cleared Special

K010561 - VERDICT -II BAR/BZO

K010561 is an FDA 510(k) clearance for VERDICT -II BAR/BZO, 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 38-day FDA review.

K010561 · Medtox Diagnostics, Inc. · Toxicology device
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Apr 2001
Decision
38d
Days
Class 2
Risk

K010561 is an FDA 510(k) clearance for the VERDICT -II BAR/BZO. 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 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 862.3150 - 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 - K010561

510(k) Number K010561 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.

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 K010561.
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
K010959 · 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
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459 · Dade Behring, Inc. · Apr 2000