DIS · Enzyme Immunoassay, Barbiturate
Clinical Toxicology · 21 CFR 862.3150 · Class 2
Overview
| Product Code | DIS |
|---|---|
| Device Name | Enzyme Immunoassay, Barbiturate |
| Regulation | 21 CFR 862.3150 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.
Classification Rationale
Class II (special controls). A barbiturate 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 barbiturate 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 100)
Showing 20 most recent of 100 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | Oct 14, 2016 | SESE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup | Assure Tech. Co., Ltd. | Jun 4, 2015 | SESE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | Apr 24, 2015 | SESE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | Guangzhou Wondfo Biotech Co., Ltd. | Jan 13, 2015 | SESE |
| K140665 | GenPrime Snap-Top Split Key Cup | Genprime, Inc. | Dec 8, 2014 | SESE |
| K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | Co-Innovation Biotech Co., Ltd. | Jun 16, 2014 | SESE |
| K092268 | RANDOX BARITURATES ASSAY | Randox Laboratories, Ltd. | May 25, 2011 | SESE |
| K110515 | UCP DRUG SCREENING TEST CUPS | Ucp Biosciences, Inc. | Apr 20, 2011 | SESE |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | Phamatech, Inc. | Dec 7, 2007 | SESE |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | Phamatech, Inc. | Dec 7, 2007 | SESE |
| K062165 | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS | Ortho-Clinical Diagnostics | Jan 5, 2007 | SESE |
| K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | Guangzhou Wondfo Biotech Co., Ltd. | Nov 17, 2005 | SESE |
| K050593 | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE | ACON Laboratories, Inc. | May 6, 2005 | SESE |
| K043211 | ONLINE DAT BARBITURATES PLUS | Roche Diagnostics Corp. | Dec 29, 2004 | SESE |
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | Ameditech, Inc. | Dec 29, 2004 | SESE |
| K041143 | RANDOX BARBITURATE ASSAY | Randox Laboratories, Ltd. | Nov 5, 2004 | SESE |
| K041712 | 'RAPIDTEC 4' TEST | American Bio Medica Corp. | Nov 3, 2004 | SESE |
| K033885 | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) | Lin-Zhi International, Inc. | May 19, 2004 | SESE |
| K033334 | PROFILE -ER | Medtox Diagnostics, Inc. | Nov 10, 2003 | SESE |
| K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | Lin-Zhi International, Inc. | Nov 3, 2003 | SESE |
Top Applicants
- Syva Co. — 13 clearances
- Abbott Laboratories — 7 clearances
- Princeton BioMeditech Corp. — 6 clearances
- Roche Diagnostic Systems, Inc. — 6 clearances
- Medtox Diagnostics, Inc. — 4 clearances
