Cleared Traditional

K013096 - PHENCYCLIDINE

K013096 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
177d
Days
-
Risk

K013096 is an FDA 510(k) clearance for the PHENCYCLIDINE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 177 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.

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FDA 510(k) Submission Details - K013096

510(k) Number K013096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2001
Decision Date March 13, 2002
Days to Decision 177 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 87d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 62
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K013096.
ONLINE DAT PHENCYCLIDINE PLUS
K043305 · Roche Diagnostics Corp. · Jan 2005
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K041578 · Phamatech · Sep 2004
PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011
K020254 · Lin-Zhi International, Inc. · May 2002
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