Cleared Traditional

EMIT IIC PHENCYCLIDINE ASSAY (K935191) - FDA 510(k) Clearance

K935191 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
484d
Days
-
Risk

K935191 is an FDA 510(k) clearance for the EMIT IIC PHENCYCLIDINE ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 22, 1995 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Syva Co. devices

Submission Details

510(k) Number K935191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1993
Decision Date February 22, 1995
Days to Decision 484 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
397d slower than avg
Panel avg: 87d · This submission: 484d
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 K935191.
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
ONLINE DAT PHENCYCLIDINE PLUS
K043305 · Roche Diagnostics Corp. · Jan 2005