Cleared Traditional

K943993 - CEDIA DAU AMPHETAMINES ASSAY

K943993 is an FDA 510(k) clearance for CEDIA DAU AMPHETAMINES ASSAY, manufactured by Microgenics Corp.. The device is a Class 2 Chemistry device with product code DKZ cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K943993 · Microgenics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
66d
Days
Class 2
Risk

K943993 is an FDA 510(k) clearance for the CEDIA DAU AMPHETAMINES ASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - the FDA in vitro diagnostics and chemistry framework. 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.

FDA 510(k) Submission Details - K943993

510(k) Number K943993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1994
Decision Date October 21, 1994
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 89d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K943993.
EMIT(R) IIC AMPHETAMINE ASSAY
K935352 · Syva Co. · Feb 1995
ABUSIGN DOA4
K943439 · Princeton BioMeditech Corp. · Feb 1995
CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS
K944604 · Beckman-Diagnostic Systems Group · Dec 1994
MICROLINE SCREEN FOR AMPHETAMINE
K935052 · Drug Screening Systems, Inc. · Sep 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372 · Microgenics Corp. · Jul 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042 · Roche Diagnostic Systems, Inc. · Jan 1994
K943993 · CEDIA DAU AMPHETAMINES ASSAY
Download PDF FDA Summary Microgenics Corp.