DKX · Thin Layer Chromatography, Barbiturate
Clinical Toxicology · 21 CFR 862.3150 · Class 2
Overview
| Product Code | DKX |
|---|---|
| Device Name | Thin Layer Chromatography, 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K030211 | RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 | Icn Biomedicals, Inc. | Jun 13, 2003 | SESE |
| K800364 | ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 | Hoffrel Instruments, Inc. | Mar 12, 1980 | SESE |
Top Applicants
- Hoffrel Instruments, Inc. — 1 clearance
- Icn Biomedicals, Inc. — 1 clearance
