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
97–120 of 225
Cleared Apr 03, 2000
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
K992918
OraSure Technologies, Inc.
Toxicology · 217d
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 Jul 15, 1999
DBSET MULTIDRUG SCREEN TEST KIT
K990681
Ameritek, Inc.
Toxicology · 135d
Cleared Jun 30, 1999
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
K992033
American Bio Medica Corp.
Toxicology · 14d
Cleared Jun 24, 1999
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
K990325
Syntron Bioresearch, Inc.
Toxicology · 142d
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 26, 1999
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST
K984525
American Bio Medica Corp.
Toxicology · 67d
Cleared Feb 23, 1999
ONTRAK TESTCUP-5 M2K
K990337
Roche Diagnostics Corp.
Toxicology · 20d
Cleared Dec 31, 1998
'RAPID DRUG SCREEN' 9-PANEL
K983770
American Bio Medica Corp.
Chemistry · 66d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Aug 27, 1998
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME
K981705
American Bio Medica Corp.
Toxicology · 105d
Cleared Aug 06, 1998
DBEST AMPHETAMINES TEST KIT
K981504
Ameritek, Inc.
Toxicology · 101d
Cleared Jun 16, 1998
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
K981197
Tcpi, Inc.
Toxicology · 75d
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 Mar 20, 1998
MICRO-STRIP FOR AMPHETAMINE METABOLITES
K974611
Microdiagnostics, Inc.
Toxicology · 99d
Cleared Jan 28, 1998
STC METHAMPHETAMINE MICRO-PLATE EIA
K972989
OraSure Technologies, Inc.
Toxicology · 169d
Cleared Dec 03, 1997
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
K973784
Biosite Incorporated
Toxicology · 61d
Cleared Nov 06, 1997
FINGERPRINT DRUG SCREENING DEVICE
K973726
Applied Technology Ventures, LLC
Toxicology · 37d
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 Aug 12, 1997
VISUALINE II METHAMPHETIMINE
K972032
Sun Biomedical Laboratories, Inc.
Toxicology · 71d
Cleared Jun 26, 1997
QUIKSTRIP ONE STEP METHAMPHETAMINE
K970395
Drial Consultants, Inc.
Toxicology · 143d