Cleared Traditional

K080436 - RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052

K080436 is an FDA 510(k) clearance for RAPIDSENSE DRUGS OF ABUSE COCAINE (COC)..., manufactured by Quantrx Biomedical Corporation. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K080436

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.

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 119
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K080436.
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