Product Code: LFM FDA class 2 21 CFR 862.3300

Enzyme Immunoassay, Digitoxin

Clinical Toxicology

An enzyme immunoassay for digitoxin is a laboratory test used to quantitatively measure digitoxin levels in patient specimens to support therapeutic drug monitoring and prevent toxicity in patients receiving this cardiac glycoside for heart failure or arrhythmia management. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LFM and is regulated under 21 CFR 862.3300 within the Clinical Toxicology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: LFM
Device Class: FDA class 2
Regulation Number: 862.3300
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K062024	DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE	Jul 28, 2006	Substantially Equivalent	Dade Behring, Inc.
K012112	RANDOX DIGITOXIN	Jan 11, 2002	Substantially Equivalent	Randox Laboratories, Ltd.
K990251	DGTX FLEX REAGENT CARTRIDGE, MODEL DF36	Mar 31, 1999	Substantially Equivalent	Dade Behring, Inc.
K970546	ACS DIGITOXIN	Jul 14, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K963158	ABBOTT AXSYM DIGITOXIN (MODIFY)	Sep 10, 1996	Substantially Equivalent	Abbott Laboratories
K954420	AXSYM DIGITOXIN	Dec 29, 1995	Substantially Equivalent	Abbott Laboratories
K951631	DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS	Jun 09, 1995	Substantially Equivalent	Bayer Corp.
K943235	IMMULITE DIGITOXIN	Oct 27, 1994	Substantially Equivalent	Diagnostic Products Corp.
K942610	KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)	Oct 20, 1994	Substantially Equivalent	Eastman Kodak Company
K942619	EMIT 2000 DIGOXIN ASSAY/CALIBRATORS	Sep 20, 1994	Substantially Equivalent	Syva Co.
K915465	DIGITOXIN FPIA REAGENT SET	Jan 27, 1992	Substantially Equivalent	Sigma Diagnostics, Inc.
K913187	INNOFLUOR(TM) DIGITOXIN REAGENT SET	Sep 23, 1991	Substantially Equivalent	Intl. Bioclinical, Inc.
K913240	DIGITOXIN (FPIA) KIT	Sep 06, 1991	Substantially Equivalent	Tudor Laboratories, Inc.
K900013	MILENIA (TM) DIGITOXIN	Mar 09, 1990	Substantially Equivalent	Diagnostic Products Corp.
K896021	CEDIA DIGITOXIN ASSAY	Nov 08, 1989	Substantially Equivalent	Microgenics Corp.
K891094	ACA(R) DIGITOXIN (DGTX) METHOD	Apr 26, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K862067	STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY	Jun 16, 1986	Substantially Equivalent	American Dade
K842280	TDX DIGITOXIN	Aug 16, 1984	Substantially Equivalent	Abbott Laboratories
K842578	SOPHEIA/MP DIGITOXIN EIA KIT	Aug 12, 1984	Substantially Equivalent	Diagnostic Products Corp.
K830035	SOPHEIA DIGITOXIN EIA KIT & COMPONENTS	Jan 28, 1983	Substantially Equivalent	Diagnostic Products Corp.