DJR · Enzyme Immunoassay, Methadone
Clinical Toxicology · 21 CFR 862.3620 · Class 2
Overview
| Product Code | DJR |
|---|---|
| Device Name | Enzyme Immunoassay, Methadone |
| Regulation | 21 CFR 862.3620 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.
Classification Rationale
Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Special Controls
*Classification.* Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Recent Cleared Devices (20 of 63)
Showing 20 most recent of 63 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192433 | LZI Methadone II Enzyme Immunoassay | Lin-Zhi International, Inc. | Oct 4, 2019 | SESE |
| K182779 | ARK EDDP Assay | Ark Diagnostics, Inc. | Nov 21, 2018 | SESE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | Lin-Zhi International, Inc. | Jun 26, 2017 | SESE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) | W.H.P.M., Inc. | Aug 17, 2016 | SESE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) | Assure Tech. Co., Ltd. | Oct 5, 2015 | SESE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets | Immunalysis Corporation | Jul 24, 2015 | SESE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | Jun 29, 2015 | SESE |
| K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) | Guangzhou Wondfo Biotech Co., Ltd. | May 31, 2013 | SESE |
| K092272 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | Nov 18, 2010 | SESE |
| K092258 | RANDOX METABOLITE (EDDP) ASSAY | Randox Laboratories, Ltd. | Nov 9, 2010 | SESE |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | Biosite Incorporated | Apr 19, 2010 | SESE |
| K081378 | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS | Thermo Fisher Scientific | Jan 14, 2009 | SESE |
| K062637 | VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V | Ortho-Clinical Diagnostics, Inc. | Nov 22, 2006 | SESE |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Biosite Incorporated | Jun 22, 2006 | SESE |
| K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | W.H.P.M., Inc. | Jun 9, 2006 | SESE |
| K051058 | METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Mar 29, 2006 | SESE |
| K040570 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | May 10, 2004 | SESE |
| K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) | Lin-Zhi International, Inc. | Oct 10, 2003 | SESE |
| K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | Microgenics Corp. | Aug 27, 2003 | SESE |
| K023856 | VISUALINE METHADONE DIPSTRIPTEST | Sun Biomedical Laboratories, Inc. | Aug 25, 2003 | SESE |
Top Applicants
- Syva Co. — 6 clearances
- Lin-Zhi International, Inc. — 5 clearances
- Abbott Laboratories — 3 clearances
- Diagnostic Reagents, Inc. — 3 clearances
- Randox Laboratories, Ltd. — 3 clearances
