Cleared Traditional

LIVESURE PHENECYCLINE (PCP) SCREEN TESTS (K012107) - FDA 510(k) Clearance

K012107 · Pan Probe Biotech, Inc. · Toxicology device
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Jul 2001
Decision
15d
Days
-
Risk

K012107 is an FDA 510(k) clearance for the LIVESURE PHENECYCLINE (PCP) SCREEN TESTS. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Pan Probe Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on July 20, 2001 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pan Probe Biotech, Inc. devices

Submission Details

510(k) Number K012107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2001
Decision Date July 20, 2001
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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