Cleared Traditional

EMIT D.A.U. PHENCYCLIDINE ASSAY (K915728) - FDA 510(k) Clearance

K915728 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
38d
Days
-
Risk

K915728 is an FDA 510(k) clearance for the EMIT D.A.U. PHENCYCLIDINE ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 38 days - a notably fast clearance cycle.

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: 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 Syva Co. devices

Submission Details

510(k) Number K915728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date January 27, 1992
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K915728.
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