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
49–72 of 225
Cleared Jul 31, 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
K011673
ACON Laboratories, Inc.
Toxicology · 62d
Cleared Mar 30, 2001
AT HOME DRUG TEST, MODEL 9063 T
K010645
Phamatech
Toxicology · 25d
Cleared Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
K003865
Roche Diagnostics Corp.
Toxicology · 77d
Cleared Aug 07, 2000
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
K994395
Alfa Scientific Designs, Inc.
Toxicology · 223d
Cleared Aug 04, 2000
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
K994399
Alfa Scientific Designs, Inc.
Toxicology · 220d
Cleared Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
K001421
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417
Roche Diagnostics Corp.
Toxicology · 55d
Cleared May 26, 2000
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
K001397
Phamatech
Toxicology · 23d
Cleared May 17, 2000
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
K001225
Princeton BioMeditech Corp.
Toxicology · 30d
Cleared May 05, 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
K000606
Beckman Coulter, Inc.
Toxicology · 72d
Cleared May 02, 2000
CEDIA DAU AMPHASSURE ASSAY
K994380
Microgenics Corp.
Toxicology · 127d
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 Dec 30, 1999
AT HOME DRUG TEST, MODEL 9063
K994237
Phamatech
Toxicology · 14d
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 Apr 01, 1998
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131
K980865
Phamatech
Toxicology · 26d
Cleared Dec 03, 1997
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
K973784
Biosite Incorporated
Toxicology · 61d
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 Feb 16, 1996
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
K955934
Biosite Incorporated
Toxicology · 65d