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
73–96 of 225
Cleared Jul 23, 2002
'RAPIDTEC' 5A MULTIPLE DIP TEST
K021114
American Bio Medica Corp.
Toxicology · 109d
Cleared Jun 04, 2002
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
K020395
Lin-Zhi International, Inc.
Toxicology · 118d
Cleared Jun 03, 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247
Biosite Incorporated
Toxicology · 159d
Cleared Jan 10, 2002
TRIAGE TOX DRUG SCREEN, CATALOG #94000
K012745
Biosite Incorporated
Toxicology · 147d
Cleared Nov 05, 2001
ONTRAK TESTCARD 9
K012396
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Aug 27, 2001
DRI ECSTASY ENZYME IMMUNOASSAY
K012110
Microgenics Corp.
Toxicology · 52d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257
Syva Co.
Chemistry · 16d
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 Jul 25, 2001
RAPID DRUG SCREEN
K012159
American Bio Medica Corp.
Toxicology · 33d
Cleared Jul 17, 2001
VISUALINE AMPHETAMINE DIPSTRIP ASSAY
K011499
Sun Biomedical Laboratories, Inc.
Toxicology · 63d
Cleared May 17, 2001
VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
K010177
Sun Biomedical Laboratories, Inc.
Toxicology · 119d
Cleared Apr 05, 2001
VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO
K010564
Medtox Diagnostics, Inc.
Toxicology · 38d
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 Nov 16, 2000
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
K002447
American Bio Medica Corp.
Toxicology · 99d
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