Cleared Traditional

K093989 - ORAL FLUID PHENCYCLIDINE

K093989 · Roche Diagnostics · Chemistry device
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Jan 2011
Decision
397d
Days
-
Risk

K093989 is an FDA 510(k) clearance for the ORAL FLUID PHENCYCLIDINE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 25, 2011 after a review of 397 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K093989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2009
Decision Date January 25, 2011
Days to Decision 397 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 88d · This submission: 397d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 52
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K093989.
Atellica CH Phencyclidine (Pcp)
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K152176 · Immunalysis Corporation · Sep 2015
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
K101746 · Microgenics Corp. · Apr 2011
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V
K062094 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
RANDOX PHENCYCLIDINE ASSAY
K043071 · Randox Laboratories, Ltd. · Jan 2005
ONLINE DAT PHENCYCLIDINE PLUS
K043305 · Roche Diagnostics Corp. · Jan 2005