Cleared Traditional

K142129 - RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET (FDA 510(k) Clearance)

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

K142129 · Biophor Diagnostics, Inc. · Toxicology device
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Jul 2015
Decision
354d
Days
Class 2
Risk

K142129 is an FDA 510(k) clearance for the RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRAT.... Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on July 24, 2015 after a review of 354 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 Biophor Diagnostics, Inc. devices

Submission Details

510(k) Number K142129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2014
Decision Date July 24, 2015
Days to Decision 354 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
267d slower than avg
Panel avg: 87d · This submission: 354d
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 144
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