Cleared Traditional

K080436 - RAPIDSENSE DRUGS OF ABUSE COCAINE (COC)...

K080436 is the FDA 510(k) clearance for RAPIDSENSE DRUGS OF ABUSE COCAINE (COC)... by Quantrx Biomedical Corporation. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K080436 · Quantrx Biomedical Corporation · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
358d
Days
Class 2
Risk

K080436 is an FDA 510(k) clearance for the RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Quantrx Biomedical Corporation (San Diego, US). The FDA issued a Cleared decision on February 11, 2009 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantrx Biomedical Corporation devices

Submission Details

510(k) Number K080436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date February 11, 2009
Days to Decision 358 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 87d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K080436.
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
K112071 · Guangzhou Wondfo Biotech Co., Ltd. · Sep 2011
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
K101742 · Microgenics Corp. · Apr 2011
ROCHE ORAL FLUID COCAINE
K101160 · Roche Diagnostics · Feb 2011
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K062123 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
K050945 · Lin-Zhi International, Inc. · Mar 2006
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
K051578 · Immunalysis Corporation · Nov 2005