Product Code: LFG FDA class 2 21 CFR 862.3910

Radioimmunoassay, Tricyclic Antidepressant Drugs

Clinical Toxicology

A radioimmunoassay for tricyclic antidepressant drugs is a laboratory test intended to measure any of the tricyclic antidepressant drugs in serum or urine, used for therapeutic drug monitoring or toxicological screening in clinical and forensic settings. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LFG and is regulated under 21 CFR 862.3910 within the Clinical Toxicology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: LFG
Device Class: FDA class 2
Regulation Number: 862.3910
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
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)	Aug 18, 2015	Substantially Equivalent	Healgen Scientific,, LLC
K142609	CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine	Dec 18, 2014	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K112395	WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST	Sep 09, 2011	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K072062	UCP MULTIPLE DRUG SCREEN TEST CUPS	Sep 20, 2007	Substantially Equivalent	Ucp Biosciences, Inc.
K061457	UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS	Aug 21, 2006	Substantially Equivalent	Ucp Biosciences, Inc.
K021526	ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE	Jul 17, 2002	Substantially Equivalent	ACON Laboratories, Inc.
K011545	VERDICT -II TCA, VERDICT-II MTD	Jun 08, 2001	Substantially Equivalent	Medtox Diagnostics, Inc.
K980249	ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA	Mar 13, 1998	Substantially Equivalent	Princeton BioMeditech Corp.
K870823	EMIT NORTRIPTYLINE ASSAY	Mar 20, 1987	Substantially Equivalent	Syva Co.
K861155	EMIT DESIPRAMINE ASSAY	May 02, 1986	Substantially Equivalent	Syva Co.
K853113	TD TRICYCLIC ANTIDEPRESSANTS	Aug 12, 1985	Substantially Equivalent	Abbott Laboratories
K844953	EMIT DESIPRAMINE ASSAY	Jun 28, 1985	Substantially Equivalent	Syva Co.
K844952	EMIT NORTRIPTYLINE ASSAY	Jun 28, 1985	Substantially Equivalent	Syva Co.
K844951	EMIT IMIPRAMINE ASSAY	Jun 28, 1985	Substantially Equivalent	Syva Co.
K844950	EMIT AMITRIPTYLINE ASSAY	Jun 28, 1985	Substantially Equivalent	Syva Co.
K841532	ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES	May 02, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K834550	EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT	Mar 19, 1984	Substantially Equivalent	Syva Co.
K831978	EMIT SERUM TRICYCLIC ANTIDEPRESSENT	Aug 11, 1983	Substantially Equivalent	Syva Co.
K821743	EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY	Jul 02, 1982	Substantially Equivalent	Syva Co.
K821653	PROTRIPTYLINE TRI-CY TEST SET	Jun 14, 1982	Substantially Equivalent	Wien Laboratories, Inc.
K821652	DOXEPIN TRI-CY TEST SET	Jun 14, 1982	Substantially Equivalent	Wien Laboratories, Inc.