LFH · U.V. Spectrometry, Tricyclic Antidepressant Drugs
Clinical Toxicology · 21 CFR 862.3910 · Class 2
Overview
| Product Code | LFH |
|---|---|
| Device Name | U.V. Spectrometry, Tricyclic Antidepressant Drugs |
| Regulation | 21 CFR 862.3910 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.
Classification Rationale
Class II (special controls). A tricyclic antidepressant drugs 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 tricyclic antidepressant drugs 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation | Nov 17, 2023 | SESE |
| K213875 | DRI TM Tricyclics Serum Tox Assay | Microgenics Corporation | Dec 21, 2022 | SESE |
| K983268 | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | Diagnostic Reagents, Inc. | Nov 18, 1998 | SESE |
| K981801 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | Aug 25, 1998 | SESE |
| K961393 | TRICYCLICS SERUM TOX ASSAY | Diagnostic Reagents, Inc. | Jun 12, 1996 | SESE |
| K953761 | AXSYM TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | Nov 22, 1995 | SESE |
Top Applicants
- Diagnostic Reagents, Inc. — 2 clearances
- Microgenics Corporation — 2 clearances
- Abbott Laboratories — 1 clearance
- Princeton BioMeditech Corp. — 1 clearance
