Cleared Traditional

K946059 - CEDIA DAU PCP ASSAY

K946059 · Microgenics Corp. · Toxicology device

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Jan 1995

Decision

36d

Days

Risk

K946059 is an FDA 510(k) clearance for the CEDIA(R) DAU PCP ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 36 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 Microgenics Corp. devices

Submission Details

510(k) Number	K946059 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 12, 1994
Decision Date	January 17, 1995
Days to Decision	36 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

51d faster than avg

Panel avg: 87d · This submission: 36d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LCM Enzyme Immunoassay, Phencyclidine
Device Class	-

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56

Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K946059.

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K953534 · Abbott Laboratories · Oct 1995

URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE

K950183 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995

EMIT IIC PHENCYCLIDINE ASSAY

K935191 · Syva Co. · Feb 1995

CEDIA(R) DAU PCP ASSAY

K935650 · Microgenics Corp. · Apr 1994

PHENCYCLIDINE EIA ASSAY

K935320 · Diagnostic Reagents, Inc. · Dec 1993

ABUSCREEN ONLINE FOR PHENCYCLIDINE

K920935 · Roche Diagnostic Systems, Inc. · Mar 1992

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K946059

Microgenics Corp.

Concord, CA · US

BETSY SOARES-MADDOX

Regulatory profile

107 submissions 106 cleared

99% clearance rate · Active in Toxicology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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