Cleared Special

K023489 - QUICKTOX MULTIPLE DRUG DIPCARD

K023489 is an FDA 510(k) clearance for QUICKTOX MULTIPLE DRUG DIPCARD, manufactured by Branan Medical Corp.. The device is a Class 2 Toxicology device with product code DIO cleared through the Special 510(k) pathway after a 60-day FDA review.

K023489 · Branan Medical Corp. · Toxicology device
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Dec 2002
Decision
60d
Days
Class 2
Risk

K023489 is an FDA 510(k) clearance for the QUICKTOX MULTIPLE DRUG DIPCARD. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 - K023489

510(k) Number K023489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2002
Decision Date December 16, 2002
Days to Decision 60 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
27d faster than avg
Panel avg: 87d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 144
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K023489.
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
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COZART EIA COCAINE ORAL FLIUD KIT
K030234 · Cozart Bioscience , Ltd. · Apr 2003
ONLINE DAT II COCAINE II
K023281 · Roche Diagnostics Corp. · Dec 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
K023296 · Roche Diagnostics Corp. · Nov 2002
AMEDICA DRUG SCREEN COCAINE TEST
K022954 · Amedica Biotech, Inc. · Nov 2002
K023489 · QUICKTOX MULTIPLE DRUG DIPCARD
Download PDF Branan Medical Corp.