Cleared Traditional

K904765 - EMIT II PHENCYCLIDINE ASSAY

K904765 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
37d
Days
-
Risk

K904765 is an FDA 510(k) clearance for the EMIT (R) II PHENCYCLIDINE ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on November 28, 1990 after a review of 37 days - a notably fast clearance cycle.

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: 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 K904765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1990
Decision Date November 28, 1990
Days to Decision 37 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
50d faster than avg
Panel avg: 87d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K904765.
IL TEST(TM) PHENCYCLIDINE
K913743 · Instrumentation Laboratory CO · Nov 1991
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
K911153 · Immunotech Corp. · Jun 1991
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
K911725 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1991
MILENIA(TM) PCP
K902960 · Diagnostic Products Corp. · Aug 1990
HYCOR ACCUPINCH PHENCYCLIDINE TEST
K900921 · Hycor Biomedical, Inc. · Apr 1990
TDX PHENCYCLIDINE II ASSAY
K900940 · Abbott Laboratories · Apr 1990