Cleared Traditional

K993945 - BIONIKE AQ PHENCYCLIDINE (PCP) TEST

K993945 · Bionike Laboratories, Inc. · Toxicology device
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Dec 1999
Decision
18d
Days
-
Risk

K993945 is an FDA 510(k) clearance for the BIONIKE AQ PHENCYCLIDINE (PCP) TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Bionike Laboratories, Inc. (Simi Valley, US). The FDA issued a Cleared decision on December 7, 1999 after a review of 18 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 Bionike Laboratories, Inc. devices

Submission Details

510(k) Number K993945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1999
Decision Date December 07, 1999
Days to Decision 18 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 87d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 K993945.
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K972963 · Boehringer Mannheim Corp. · Sep 1997
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · Roche Diagnostic Systems, Inc. · Dec 1996