Cleared Traditional

PHENCYCLIDINE URINE ASSAY (K790401) - FDA 510(k) Clearance

K790401 · Syva Co. · Toxicology device
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Jun 1979
Decision
109d
Days
-
Risk

K790401 is an FDA 510(k) clearance for the PHENCYCLIDINE URINE ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 109 days - within the typical 510(k) review window.

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

View all Syva Co. devices

Submission Details

510(k) Number K790401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date June 15, 1979
Days to Decision 109 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 87d · This submission: 109d
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 K790401.
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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