Cleared Traditional

K981363 - ONE STEP URINE DRUG OF ABUSE: PHENCYCLI...

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

Submission Details

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
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 87d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 57
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K981363.
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
K994020 · Roche Diagnostics Corp. · Jan 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
K994030 · Roche Diagnostics Corp. · Jan 2000
AT HOME DRUG TEST, MODEL 9133
K994236 · Phamatech · Dec 1999
QUICKSCREEN ONE STEP PCP SCREENING TEST
K974582 · Phamatech · Feb 1998
MODIFIED CEDIA DAU PCP ASSAY
K972963 · Boehringer Mannheim Corp. · Sep 1997
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · Roche Diagnostic Systems, Inc. · Dec 1996