Cleared Traditional

K012107 - LIVESURE PHENECYCLINE (PCP) SCREEN TESTS

K012107 · Pan Probe Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K012107

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
Combination Product No
PCCP Authorized No
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.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Consultant

California Department of Health Services
JAMES M BARQUEST

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 87
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K012107.
PHENCYCLIDINE
K013096 · Abbott Laboratories · Mar 2002
AMEDITECH IMMUTEST DRUG SCREEN PCP
K012582 · Ameditech, Inc. · Nov 2001
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE
K011730 · ACON Laboratories, Inc. · Aug 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST
K010045 · Alfa Scientific Designs, Inc. · May 2001
INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST
K010047 · Alfa Scientific Designs, Inc. · May 2001
MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
K011161 · Syva Co., Dade Behring, Inc. · May 2001
K012107 · LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
Download PDF FDA Summary Pan Probe Biotech, In…