Cleared Traditional

K103295 - QUICKSCREEN COCAINE 150 SCREENING TEST (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103295 · Phamatech, Inc. · Toxicology device
Feb 2012
Decision
450d
Days
Class 2
Risk

K103295 is an FDA 510(k) clearance for the QUICKSCREEN COCAINE 150 SCREENING TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 1, 2012 after a review of 450 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

Submission Details

510(k) Number K103295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2010
Decision Date February 01, 2012
Days to Decision 450 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
304d slower than avg
Panel avg: 146d · This submission: 450d
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.

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