Cleared Special

K011545 - VERDICT -II TCA, VERDICT-II MTD

K011545 is an FDA 510(k) clearance for VERDICT -II TCA, manufactured by Medtox Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code LFG cleared through the Special 510(k) pathway after a 21-day FDA review.

K011545 · Medtox Diagnostics, Inc. · Toxicology device
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Jun 2001
Decision
21d
Days
Class 2
Risk

K011545 is an FDA 510(k) clearance for the VERDICT -II TCA, VERDICT-II MTD. Classified as Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG), Class II - Special Controls.

Submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on June 8, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3910 - 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 - K011545

510(k) Number K011545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2001
Decision Date June 08, 2001
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

LFG Device Classification - Class 2, Special Controls

Product Code LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
Definition Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.
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 - LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

All 20
Devices cleared under the same product code (LFG) and FDA review panel - the closest regulatory comparables to K011545.
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UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS
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ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K021526 · ACON Laboratories, Inc. · Jul 2002
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
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EMIT NORTRIPTYLINE ASSAY
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EMIT DESIPRAMINE ASSAY
K861155 · Syva Co. · May 1986
K011545 · VERDICT -II TCA, VERDICT-II MTD
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