Cleared Traditional

PHENCYCLIDINE (K013096) - FDA 510(k) Clearance

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.

View all Abbott Laboratories devices

Submission Details

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.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 37
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K013096.
ORAL FLUID PHENCYCLIDINE
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RANDOX PHENCYCLIDINE ASSAY
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K043305 · Roche Diagnostics Corp. · Jan 2005
URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
K000462 · Dade Behring, Inc. · Apr 2000
SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL
K993983 · Syva Co. · Jan 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
K994017 · Roche Diagnostics Corp. · Jan 2000