Enzyme Immunoassay, Methadone
FDA product code DJR · Class II (moderate risk) · 21 CFR 862.3620 · Clinical Toxicology
63510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Syva Co. 6
- Lin-Zhi International, Inc. 5
- Abbott Laboratories 3
- W.H.P.M., Inc. 3
- Diagnostic Reagents, Inc. 3
- Randox Laboratories, Ltd. 3
- Microgenics Corp. 2
- American Bio Medica Corp. 2
- Alfa Scientific Designs, Inc. 2
- Roche Diagnostics Corp. 2
- Biosite Incorporated 2
- Sun Biomedical Laboratories, Inc. 2
- Princeton BioMeditech Corp. 2
- Beckman Instruments, Inc. 2
- Roche Diagnostic Systems, Inc. 2
- Diagnostic Products Corp. 2
- Boehringer Mannheim Corp. 1
- Ark Diagnostics, Inc. 1
- Solarcare Technologies Corp,Inc. 1
- OraSure Technologies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 10/04/2019SE |
| K182779 | ARK EDDP AssayDJR · Traditional | Ark Diagnostics, Inc. | 11/21/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | W.H.P.M., Inc. | 08/17/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | Assure Tech. Co., Ltd. | 10/05/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
| K092048 | One Step Eddp (Methadone Metabolite) Test StripDJR · Traditional | Biosite Incorporated | 04/19/2010SE |
| K081378 | Dri Methadone Metabolite (100/300) Assay, Calibrators and ControlsDJR · Traditional | Thermo Fisher Scientific | 01/14/2009SE |
| K062637 | Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I…DJR · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/22/2006SE |
| K060791 | Triage Tox Drug Screen, Model 94400DJR · Traditional | Biosite Incorporated | 06/22/2006SE |
| K052197 | First Sign Drug of Abuse Urine Screening TestDJR · Traditional | W.H.P.M., Inc. | 06/09/2006SE |
| K051058 | Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsDJR · Traditional | Lin-Zhi International, Inc. | 03/29/2006SE |
| K040570 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 05/10/2004SE |
| K031797 | Methadone Metabolite (Eddp) Enzime Immunoassay, Cat. No. 190 (500 Test Kit), No. 191…DJR · Traditional | Lin-Zhi International, Inc. | 10/10/2003SE |
| K023617 | Dri Methadone Metabolite Enzyme ImmunoassayDJR · Traditional | Microgenics Corp. | 08/27/2003SE |
| K023856 | Visualine Methadone DipstriptestDJR · Traditional | Sun Biomedical Laboratories, Inc. | 08/25/2003SE |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE Dip TestDJR · Traditional | American Bio Medica Corp. | 04/30/2003SE |
| K023317 | Methadone Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 12/12/2002SE |
| K023252 | Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020DJR · Traditional | Icn Biomedicals, Inc. | 11/22/2002SE |
| K021512 | Cobas Integra Online Dat II Methadone IIDJR · Traditional | Roche Diagnostics Corp. | 07/16/2002SE |
| K021505 | Online Dat II Methadone IIDJR · Traditional | Roche Diagnostics Corp. | 07/16/2002SE |
| K013001 | MethadoneDJR · Traditional | Abbott Laboratories | 03/20/2002SE |
| K013796 | Livesure Methadone Screen TestsDJR · Traditional | Pan Probe Biotech, Inc. | 11/26/2001SE |
| K012164 | 'Rapidone'-Methadone TestDJR · Traditional | American Bio Medica Corp. | 11/20/2001SE |
| K012595 | Acon MTD One Step Methadone Test Strip and Test DeviceDJR · Traditional | ACON Laboratories, Inc. | 10/15/2001SE |
| K011131 | Methadone Microplate Eia Urine ApplicationDJR · Traditional | Cozart Bioscience , Ltd. | 07/31/2001SE |
| K010015 | Instant-View Methadone Urine Cassette TestDJR · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K010014 | Instant-View Methadone Urine Dip Strip TestDJR · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K010962 | Emit II Plus Methadone Assay, Model OSRE229DJR · Special | Syva Co., Dade Behring, Inc. | 04/26/2001SE |
| K002010 | STC Methadone Intercept Micro-Plate Eia, Model 11421DJR · Traditional | OraSure Technologies, Inc. | 11/29/2000SE |
| K002417 | Branan Medical Corporation Monitect Methadone Drug Screen Test, Model 190C and 190DDJR · Traditional | Branan Medical Corporation | 11/22/2000SE |
| K000466 | Urine Methadone (Meth) Screen Flex Reagent Cartridge, Catalog No. DF 93ADJR · Traditional | Dade Behring, Inc. | 04/05/2000SE |
| K994005 | Syva Emit II Plus Methadone Assay, Models 9E029UL/9E129ULDJR · Traditional | Syva Co. | 01/20/2000SE |
| K991080 | Accusign MTD, Biosign MTDDJR · Special | Princeton BioMeditech Corp. | 04/15/1999SE |
| K982938 | Quick Screen Methadone Screening Test, Models 9035, 9036, Quick Screen Pro Multi Drug…DJR · Traditional | Phamatech | 02/05/1999SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | Roche Diagnostic Systems, Inc. | 12/11/1998SE |
| K981314 | Visualine II (Also Known AS Sunline) MethadoneDJR · Traditional | Sun Biomedical Laboratories, Inc. | 09/04/1998SE |
| K980746 | Cedia Dau Eddp AssayDJR · Traditional | Boehringer Mannheim Corp. | 05/26/1998SE |
| K973069 | Synchron Systems Methadone ReagentDJR · Traditional | Beckman Instruments, Inc. | 09/22/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | Diagnostic Reagents, Inc. | 08/04/1997SE |
| K962673 | Accusign Mtd-Rapid One-Step Methadone AssayDJR · Traditional | Princeton BioMeditech Corp. | 08/15/1996SE |
| K954227 | Cedia Dau Methadone AssayDJR · Traditional | Microgenics Corp. | 11/17/1995SE |
| K953499 | Axsym MethadoneDJR · Traditional | Abbott Laboratories | 11/13/1995SE |
| K944056 | Auto-Lyte Methadone DiaDJR · Traditional | Solarcare Technologies Corp,Inc. | 12/29/1994SE |
| K944074 | Cx(Tm) Methadone(Metd) Reagent for Synchron CX SystDJR · Traditional | Beckman Instruments, Inc. | 12/02/1994SE |
| K934667 | Methadone Enzyme ImmunoassayDJR · Traditional | Diagnostic Reagents, Inc. | 01/26/1994SE |
| K934147 | Dupont Aca Methadone (Umeth) Screen Test PackDJR · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/09/1993SE |
| K930928 | Roche Abuscreen Online for MethadoneDJR · Traditional | Roche Diagnostic Systems, Inc. | 09/24/1993SE |
| K931780 | Methadone Metabolite Eia AssayDJR · Traditional | Diagnostic Reagents, Inc. | 08/23/1993SE |
| K920858 | Il Test MethadoneDJR · Traditional | Instrumentation Laboratory CO | 04/24/1992SE |
| K920751 | Syva Emit II Methadone AssayDJR · Traditional | Syva Co. | 03/13/1992SE |
| K911954 | Remedi(Tm) Drug Profiling System, ModificationDJR · Traditional | Bio-Rad | 05/23/1991SE |
| K884968 | TDX Methadone AssayDJR · Traditional | Abbott Laboratories | 12/16/1988SE |
| K873899 | Revised Labeling for Syva Methadone AssaysDJR · Traditional | Syva Co. | 10/28/1987SE |
| K873750 | Labeling Changes Coat-A-Count Methadone in UrineDJR · Traditional | Diagnostic Products Corp. | 10/15/1987SE |
| K870937 | Coat-A-Count Methadone TKMD1DJR · Traditional | Diagnostic Products Corp. | 03/19/1987SE |
| K850953 | Emit 700 Methadone AssayDJR · Traditional | Syva Co. | 04/01/1985SE |
| K842676 | Emit D.A.U. Methadone AssayDJR · Traditional | Syva Co. | 09/26/1984SE |
| K840060 | Emit ST Urine Methadone AssayDJR · Traditional | Syva Co. | 03/19/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2140-2018 Class III | lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75…The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100… | Alere San Diego Inc. DBA Immunalysis… | 11/28/2017Terminated |
| Z-1214-2014 Class II | Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots…Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots… | Alere San Diego, Inc. | 02/05/2014Terminated |
| Z-2039-2012 Class II | Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug…A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have… | Alere San Diego, Inc. | 05/14/2012Terminated |
| Z-1446-2012 | Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually…The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected… | Alere San Diego dba Biosite Innovacon… | 03/12/2010Terminated |
| Z-0029-2013 Class II | Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is…Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was… | Alere San Diego, Inc. | 05/28/2009Terminated |
| Z-1875-2008 | VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip…Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | Sun Biomedical Laboratories, Inc. | 05/28/2008Terminated |
| Z-1873-2008 | VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by…Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. | Sun Biomedical Laboratories, Inc. | 05/28/2008Terminated |