LFG · Radioimmunoassay, Tricyclic Antidepressant Drugs
Clinical Toxicology · 21 CFR 862.3910 · Class 2
Overview
| Product Code | LFG |
|---|---|
| Device Name | Radioimmunoassay, 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 (20 of 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151348 | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | Aug 18, 2015 | SESE |
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | Dec 18, 2014 | SESE |
| K112395 | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | Sep 9, 2011 | SESE |
| K072062 | UCP MULTIPLE DRUG SCREEN TEST CUPS | Ucp Biosciences, Inc. | Sep 20, 2007 | SESE |
| K061457 | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS | Ucp Biosciences, Inc. | Aug 21, 2006 | SESE |
| K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | ACON Laboratories, Inc. | Jul 17, 2002 | SESE |
| K011545 | VERDICT -II TCA, VERDICT-II MTD | Medtox Diagnostics, Inc. | Jun 8, 2001 | SESE |
| K980249 | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | Princeton BioMeditech Corp. | Mar 13, 1998 | SESE |
| K870823 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | Mar 20, 1987 | SESE |
| K861155 | EMIT DESIPRAMINE ASSAY | Syva Co. | May 2, 1986 | SESE |
| K853113 | TD TRICYCLIC ANTIDEPRESSANTS | Abbott Laboratories | Aug 12, 1985 | SESE |
| K844953 | EMIT DESIPRAMINE ASSAY | Syva Co. | Jun 28, 1985 | SESE |
| K844952 | EMIT NORTRIPTYLINE ASSAY | Syva Co. | Jun 28, 1985 | SESE |
| K844951 | EMIT IMIPRAMINE ASSAY | Syva Co. | Jun 28, 1985 | SESE |
| K844950 | EMIT AMITRIPTYLINE ASSAY | Syva Co. | Jun 28, 1985 | SESE |
| K841532 | ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES | E.I. Dupont DE Nemours & Co., Inc. | May 2, 1984 | SESE |
| K834550 | EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT | Syva Co. | Mar 19, 1984 | SESE |
| K831978 | EMIT SERUM TRICYCLIC ANTIDEPRESSENT | Syva Co. | Aug 11, 1983 | SESE |
| K821743 | EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY | Syva Co. | Jul 2, 1982 | SESE |
| K821653 | PROTRIPTYLINE TRI-CY TEST SET | Wien Laboratories, Inc. | Jun 14, 1982 | SESE |
Top Applicants
- Syva Co. — 9 clearances
- Guangzhou Wondfo Biotech Co., Ltd. — 2 clearances
- Ucp Biosciences, Inc. — 2 clearances
- Wien Laboratories, Inc. — 2 clearances
- ACON Laboratories, Inc. — 1 clearance
