JXM · Enzyme Immunoassay, Benzodiazepine
Clinical Toxicology · 21 CFR 862.3170 · Class 2
Overview
| Product Code | JXM |
|---|---|
| Device Name | Enzyme Immunoassay, Benzodiazepine |
| Regulation | 21 CFR 862.3170 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.
Classification Rationale
Class II (special controls). A benzodiazepine 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 benzodiazepine 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 90)
Showing 20 most recent of 90 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent Kit | Microgenics Corporation | Dec 11, 2024 | SESE |
| K221765 | ONLINE DAT Benzodiazepines II | Roche Diagnostics | Dec 23, 2022 | SESE |
| K190968 | CEDIA Benzodiazepine Assay | Microgenics Corporation | Dec 9, 2019 | SESE |
| K173963 | DRI Benzodiazepine Assay | Microgenics Corporation | Feb 21, 2018 | SESE |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in Hair | Psychemedics Corporation | Sep 15, 2017 | SESE |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | Aug 2, 2017 | SESE |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | May 23, 2016 | SESE |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | Jan 5, 2016 | SESE |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | Aug 13, 2015 | SESE |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | May 13, 2015 | SESE |
| K123080 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS | Chemtron Biotech, Inc. | Nov 29, 2012 | SESE |
| K111322 | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD | Chemtron Biotech, Inc. | Sep 14, 2011 | SESE |
| K092274 | RANDOX BENZODIAZEPINE ASSAY | Randox Laboratories, Ltd. | Oct 15, 2010 | SESE |
| K062285 | VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV | Ortho-Clinical Diagnostics, Inc. | Dec 22, 2006 | SESE |
| K060354 | ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 | Acro Biotech, LLC | Jul 28, 2006 | SESE |
| K051307 | SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT | Beckman Coulter, Inc. | Jun 13, 2005 | SESE |
| K050179 | RANDOX BENZODIAZEPINE CLASS ASSAY | Randox Laboratories, Ltd. | May 17, 2005 | SESE |
| K043556 | SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT | Beckman Coulter, Inc. | Mar 28, 2005 | SESE |
| K043327 | ONLINE DAT BENZODIAZEPINES PLUS | Roche Diagnostics Corp. | Feb 7, 2005 | SESE |
| K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | Phamatech, Inc. | Dec 29, 2004 | SESE |
Top Applicants
- Syva Co. — 13 clearances
- Abbott Laboratories — 8 clearances
- Roche Diagnostic Systems, Inc. — 7 clearances
- Healgen Scientific,, LLC — 4 clearances
- Microgenics Corp. — 4 clearances
