Cleared Traditional

K080431 - RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054

K080431 · Quantrx Biomedical Corporation · Toxicology device
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Jan 2009
Decision
324d
Days
-
Risk

K080431 is an FDA 510(k) clearance for the RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Quantrx Biomedical Corporation (San Diego, US). The FDA issued a Cleared decision on January 8, 2009 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 - K080431

510(k) Number K080431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date January 08, 2009
Days to Decision 324 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
237d slower than avg
Panel avg: 87d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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