Cleared Traditional

K981363 - ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST

K981363 · Tcpi, Inc. · Toxicology device
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Dec 1998
Decision
251d
Days
-
Risk

K981363 is an FDA 510(k) clearance for the ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Tcpi, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 251 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 Tcpi, Inc. devices

FDA 510(k) Submission Details - K981363

510(k) Number K981363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1998
Decision Date December 22, 1998
Days to Decision 251 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
164d slower than avg
Panel avg: 87d · This submission: 251d
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 75
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K981363.
REDI-TEST PCP
K991698 · Redwood Biotech, Inc. · Aug 1999
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
K991505 · Microdiagnostics, Inc. · Aug 1999
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
K983790 · Sun Biomedical Laboratories, Inc. · Mar 1999
AUTO-LYTE PCP EIA, MODEL #1254U
K982801 · OraSure Technologies, Inc. · Nov 1998
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
K981292 · Syntron Bioresearch, Inc. · May 1998
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
K981019 · Syntron Bioresearch, Inc. · May 1998