Cleared Traditional

K950183 - URINE PHENCYCLIDINE SCREEN FLEX(TM) REA...

K950183 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device

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Mar 1995

Decision

62d

Days

Risk

K950183 is an FDA 510(k) clearance for the URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 20, 1995 after a review of 62 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number	K950183 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 17, 1995
Decision Date	March 20, 1995
Days to Decision	62 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

25d faster than avg

Panel avg: 87d · This submission: 62d

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 K950183.

ONTRAK TESTCUP 5 (MODIFICATION)

K964355 · Roche Diagnostic Systems, Inc. · Dec 1996

ACCUSIGN, BIOSIGN PCP

K961266 · Princeton BioMeditech Corp. · May 1996

AXSYM PHENCYCLIDINE II

K953534 · Abbott Laboratories · Oct 1995

EMIT IIC PHENCYCLIDINE ASSAY

K935191 · Syva Co. · Feb 1995

CEDIA(R) DAU PCP ASSAY

K946059 · Microgenics Corp. · Jan 1995

CEDIA(R) DAU PCP ASSAY

K935650 · Microgenics Corp. · Apr 1994

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 K950183

E.I. Dupont DE Nemours & Co., Inc.

Wilmington, DE · US

CAROLYN K GEORGE

Regulatory profile

253 submissions 252 cleared

100% clearance rate · Active in Toxicology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

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

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