Cleared Traditional

K935352 - EMIT IIC AMPHETAMINE ASSAY

K935352 is the FDA 510(k) clearance for EMIT IIC AMPHETAMINE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 474-day FDA review.

K935352 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
474d
Days
Class 2
Risk

K935352 is an FDA 510(k) clearance for the EMIT(R) IIC AMPHETAMINE ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on February 22, 1995 after a review of 474 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. 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 K935352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1993
Decision Date February 22, 1995
Days to Decision 474 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
387d slower than avg
Panel avg: 87d · This submission: 474d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K935352.
CEDIA DAU AMPHETAMINES ASSAY
K951154 · Microgenics Corp. · May 1995
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
K945610 · Princeton BioMeditech Corp. · Apr 1995
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950135 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995
ABUSIGN DOA4
K943439 · Princeton BioMeditech Corp. · Feb 1995
CEDIA DAU AMPHETAMINES ASSAY
K943993 · Microgenics Corp. · Oct 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372 · Microgenics Corp. · Jul 1994