Cleared Traditional

K981019 - QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) ...

K981019 · Syntron Bioresearch, Inc. · Toxicology device
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May 1998
Decision
50d
Days
-
Risk

K981019 is an FDA 510(k) clearance for the QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syntron Bioresearch, Inc. (Simi Valley, US). The FDA issued a Cleared decision on May 7, 1998 after a review of 50 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.

View all Syntron Bioresearch, Inc. devices

Submission Details

510(k) Number K981019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1998
Decision Date May 07, 1998
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
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 K981019.
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
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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