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
121–144 of 225
Cleared May 30, 1997
QUIKSTRIP ONE STEP AMPHETAMINE TEST
K971218
Drial Consultants, Inc.
Toxicology · 58d
Cleared May 14, 1997
QUIKPAC II ONE STEP AMPHETAMINE TEST
K971109
Drial Consultants, Inc.
Toxicology · 49d
Cleared May 13, 1997
QUICKPAC II ONE STEP METHAMPHETAMINE TEST
K970724
Drial Consultants, Inc.
Toxicology · 75d
Cleared Apr 08, 1997
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
K970265
Drial Consultants, Inc.
Toxicology · 75d
Cleared Oct 07, 1996
ONTRAK TESTCUP AMPHETAMINES
K962411
Roche Diagnostic Systems, Inc.
Toxicology · 108d
Cleared Feb 16, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
K955934
Biosite Incorporated
Toxicology · 65d
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 Jul 14, 1995
AMPHETAMINES MICRO-PLATE EIA
K935573
Solarcare Technologies Corp,Inc.
Toxicology · 603d
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 Jul 20, 1993
SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY
K931498
Solarcare Technologies Corp,Inc.
Toxicology · 117d
Cleared Apr 16, 1993
STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA
K930690
Solarcare Technologies Corp,Inc.
Toxicology · 65d
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