DKZ · Class II · 21 CFR 862.3100

FDA Product Code DKZ: Enzyme Immunoassay, Amphetamine

Amphetamine detection is critical in emergency toxicology, workplace safety, and substance abuse treatment programs. FDA product code DKZ covers enzyme immunoassay systems for amphetamine detection in biological specimens.

These tests use antibody-based technology to screen for amphetamines and methamphetamines in urine, providing a rapid initial result that guides clinical management and triggers confirmatory testing when positive.

DKZ devices are Class II medical devices, regulated under 21 CFR 862.3100 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Roche Diagnostic Systems, Inc., Syva Co. and Roche Diagnostics Corp..

225
Total
225
Cleared
111d
Avg days
1976
Since
225 devices
73–96 of 225
Cleared Feb 15, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
K955935
Biosite Incorporated
Toxicology · 64d
Cleared Oct 06, 1995
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115
Abbott Laboratories
Toxicology · 95d
Cleared May 08, 1995
CEDIA DAU AMPHETAMINES ASSAY
K951154
Microgenics Corp.
Toxicology · 55d
Cleared Apr 13, 1995
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
K945610
Princeton BioMeditech Corp.
Toxicology · 149d
Cleared Mar 30, 1995
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950135
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 76d
Cleared Feb 22, 1995
EMIT(R) IIC AMPHETAMINE ASSAY
K935352
Syva Co.
Toxicology · 474d
Cleared Feb 22, 1995
ABUSIGN DOA4
K943439
Princeton BioMeditech Corp.
Toxicology · 219d
Cleared Oct 21, 1994
CEDIA DAU AMPHETAMINES ASSAY
K943993
Microgenics Corp.
Chemistry · 66d
Cleared Jul 20, 1994
CEDIA DAU AMPHETAMINES ASSAY
K941372
Microgenics Corp.
Toxicology · 120d
Cleared Jan 25, 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Jan 13, 1994
AMPHETAMINES EIA ASSAY MODIFICATION
K934891
Diagnostic Reagents, Inc.
Toxicology · 114d
Cleared Sep 15, 1993
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
K933052
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Jan 22, 1993
THE TRIAGE II
K924476
Biosite Incorporated
Toxicology · 141d
Cleared May 26, 1992
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
K921998
Roche Diagnostic Systems, Inc.
Toxicology · 33d
Cleared May 04, 1992
AMPHETAMINES EIA TEST
K921554
Diagnostic Reagents, Inc.
Toxicology · 33d
Cleared Feb 27, 1992
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
K920507
Syva Co.
Toxicology · 22d
Cleared Nov 07, 1991
IL TEST(TM) AMPHETAMINE
K913738
Instrumentation Laboratory CO
Toxicology · 79d
Cleared Oct 11, 1991
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE
K914146
Biosite Incorporated
Toxicology · 25d
Cleared Jul 26, 1991
ABUSCREEN ONLINE FOR AMPHETAMINES
K912758
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Apr 03, 1991
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
K910278
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Apr 03, 1991
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
K910658
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Mar 11, 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Dec 20, 1990
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
K903993
Immunotech Corp.
Chemistry · 113d
Cleared Nov 28, 1990
HYCOR ACCUPINCH METHAMPHETAMINE TEST
K904115
Hycor Biomedical, Inc.
Toxicology · 83d