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
145–168 of 225
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 21, 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)
K910739
V-Tech, Inc.
Toxicology · 28d
Cleared Mar 19, 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
K910738
V-Tech, Inc.
Toxicology · 26d
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
Cleared Nov 21, 1990
MILENIA (TM) METHAMPHETAMINE
K904451
Diagnostic Products Corp.
Chemistry · 54d
Cleared Sep 27, 1990
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
K903824
Technicon Instruments Corp.
Toxicology · 38d
Cleared Sep 07, 1990
MILENIA (TM) AMPHETAMINE
K902979
Diagnostic Products Corp.
Chemistry · 67d
Cleared Apr 20, 1990
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
K900995
Syva Co.
Toxicology · 50d
Cleared Mar 09, 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143
Roche Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Sep 25, 1989
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
K895210
Abbott Laboratories
Toxicology · 38d
Cleared Aug 25, 1989
ADX AMPHETAMINE/METHAMPHEAMINE
K890692
Abbott Laboratories
Toxicology · 196d
Cleared Aug 15, 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Aug 11, 1989
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K894404
Syva Co.
Toxicology · 25d
Cleared Mar 10, 1989
ABUSCREEN FP FOR AMPHETAMINE
K890886
Roche Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Oct 20, 1988
TDX AMPHETAMINE/METHAMPHETAMINE II
K883707
Abbott Laboratories
Chemistry · 51d
Cleared Oct 11, 1988
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K884022
Syva Co.
Toxicology · 19d
Cleared Aug 02, 1988
EMIT HVA AMPHETAMINE ASSAY
K882589
Syva Co.
Toxicology · 40d