Cleared Traditional

K122703 - RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR (FDA 510(k) Clearance)

K122703 · Biophor Diagnostics, Inc. · Toxicology device
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Apr 2013
Decision
233d
Days
-
Risk

K122703 is an FDA 510(k) clearance for the RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND .... Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Biophor Diagnostics, Inc. (Redwood City, US). The FDA issued a Cleared decision on April 25, 2013 after a review of 233 days - an extended review cycle.

This device falls under the Toxicology FDA review panel. 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. Standard predicate reliance. 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 K122703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date April 25, 2013
Days to Decision 233 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
146d slower than avg
Panel avg: 87d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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