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
25–48 of 225
Cleared May 05, 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606
Beckman Coulter, Inc.
Toxicology · 72d
Cleared Apr 14, 2000
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460
Dade Behring, Inc.
Toxicology · 63d
Cleared Jan 27, 2000
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632
Diagnostic Products Corp.
Toxicology · 174d
Cleared Apr 15, 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 13, 1999
ONTRAK TESTCUP-ER M2K
K990418
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Feb 23, 1999
ONTRAK TESTCUP-5 M2K
K990337
Roche Diagnostics Corp.
Toxicology · 20d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Oct 09, 1997
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
K973075
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Oct 01, 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
K972891
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Oct 07, 1996
ONTRAK TESTCUP AMPHETAMINES
K962411
Roche Diagnostic Systems, Inc.
Toxicology · 108d
Cleared Oct 06, 1995
AXSYM AMPHETAMINE/METHAMPHETAMINE II
K953115
Abbott Laboratories
Toxicology · 95d
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 Jan 25, 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Sep 15, 1993
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
K933052
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared May 26, 1992
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
K921998
Roche Diagnostic Systems, 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 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 Nov 21, 1990
MILENIA (TM) METHAMPHETAMINE
K904451
Diagnostic Products Corp.
Chemistry · 54d
Cleared Sep 07, 1990
MILENIA (TM) AMPHETAMINE
K902979
Diagnostic Products Corp.
Chemistry · 67d