Cleared Traditional

ORAL FLUID PHENCYCLIDINE (K093989) - FDA 510(k) Clearance

K093989 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Roche Diagnostics devices

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
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 87
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K093989.
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair
K212952 · Psychemedics Corporation · Apr 2022
SEFRIA PCP Oral Fluid Enzyme Immunoassay
K203489 · Immunalysis Corporation · Apr 2021
Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
K181135 · Immunalysis Corporation · Jan 2019
Atellica CH Phencyclidine (Pcp)
K163220 · Siemens Healthcare Diagnostics, Inc. · Apr 2017
Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K152176 · Immunalysis Corporation · Sep 2015
PHENCYCLIDINE
K013096 · Abbott Laboratories · Mar 2002