Product Code: LBZ FDA class 2 21 CFR 862.3320

Enzyme Immunoassay, Quinidine

Clinical Toxicology

Enzyme immunoassay for quinidine is a laboratory test system used in clinical toxicology to measure serum concentrations of quinidine, an antiarrhythmic drug with a narrow therapeutic index that requires monitoring to prevent toxicity. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LBZ, regulated under 21 CFR 862.3320, in the Clinical Toxicology specialty. Third-party review is available for this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LBZ
Device Class: FDA class 2
Regulation Number: 862.3320
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 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K052826	QMS QUINIDINE. QMS QUINIDINE CALIBRATORS	Dec 23, 2005	Substantially Equivalent	Seradyn, Inc.
K032332	ROCHE ONLINE TDM QUINIDINE	Jan 12, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K011605	EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229	Jun 12, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K964116	QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)	Dec 24, 1996	Substantially Equivalent	Bayer Corp.
K964212	QUINIDINE ENZYME IMMUNOASSAY	Dec 18, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K955568	INNOFLUOR QUINIDINE ASSAY SYSTEM	Apr 04, 1996	Substantially Equivalent	Oxis Intl., Inc.
K941440	COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS	Jul 06, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K922913	EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS	Aug 24, 1992	Substantially Equivalent	Syva Co.
K904990	EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS	Feb 04, 1991	Substantially Equivalent	Syva Co.
K900705	MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR	Apr 12, 1990	Substantially Equivalent	Innotron of Oregon, Inc.
K892208	INNOFLUOR(TM) QUINIDINE REAGENT SET	Jun 09, 1989	Substantially Equivalent	Innotron of Oregon, Inc.
K872175	TDXR FLECAINIDE	Aug 13, 1987	Substantially Equivalent	Abbott Laboratories
K864607	EASY-TEST QUINIDINE ITEM NO. 67---/95	Jan 08, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862214	EMIT QUINIDINE ASSAY	Jun 27, 1986	Substantially Equivalent	Syva Co.
K860049	DETERMINATION OF QUINIDINE	Jan 22, 1986	Substantially Equivalent	Clinical Data, Inc.
K850808	COBAS FP REAGENTS FOR QUINIDINE	Mar 25, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K843237	STRATUS QUINIDINE FLUOROMETRIC ENZYME	Sep 12, 1984	Substantially Equivalent	American Dade
K842713	TDX DISOPYRAMIDE	Aug 29, 1984	Substantially Equivalent	Abbott Laboratories
K840596	QUINIDINE ANALYTICAL TEST PACK	Apr 04, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832493	QUINIDINE FLUORESCENT IMMUNOASSAY	Sep 12, 1983	Substantially Equivalent	American Diagnostic Corp.
K832096	EMIT CAD QUINIDINE ASSAY FOR USE W/	Aug 08, 1983	Substantially Equivalent	Syva Co.
K830963	QUINIDINE REAGENT TEST KIT	Jun 30, 1983	Substantially Equivalent	Beckman Instruments, Inc.
K831355	EMIT QST QUINIDINE ASSAY	Jun 02, 1983	Substantially Equivalent	Syva Co.
K822653	TDX QUINIDINE	Sep 28, 1982	Substantially Equivalent	Abbott Laboratories
K822588	ADVANCE EMIT-CAD QUINIDINE ASSAY	Sep 17, 1982	Substantially Equivalent	Syva Co.
K812753	AMES TDA QUINIDINE TEST	Oct 19, 1981	Substantially Equivalent	Miles Laboratories, Inc.
K811460	EMIT-CAD QUINIDINE ASSAY	Jun 09, 1981	Substantially Equivalent	Syva Co.