Cleared Traditional

K993945 - BIONIKE AQ PHENCYCLIDINE (PCP) TEST

K993945 · Bionike Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K993945

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
Combination Product No
PCCP Authorized No
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.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Consultant

California Department of Health Services
JAMES M BARQUEST

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K993945.
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K991505 · Microdiagnostics, Inc. · Aug 1999
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K983790 · Sun Biomedical Laboratories, Inc. · Mar 1999