Product Code: KLR FDA class 2 21 CFR 862.3555

Enzyme Immunoassay, Lidocaine

Clinical Toxicology

The Lidocaine Enzyme Immunoassay is an in vitro diagnostic test used in clinical toxicology laboratories to measure lidocaine serum concentrations, supporting therapeutic drug monitoring during antiarrhythmic or local anesthetic therapy to guide dosing and prevent toxicity. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLR and it is regulated under 21 CFR 862.3555 in 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: KLR
Device Class: FDA class 2
Regulation Number: 862.3555
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 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K090282	QMS LIDOCAINE	May 29, 2009	Substantially Equivalent	Thermo Fisher Scientific, Inc.
K033809	DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D	Feb 20, 2004	Substantially Equivalent	Dade Behring, Inc.
K032334	ROCHE ONLINE TDM LIDOCAINE	Jan 12, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K973102	LIDOCAINE EIA ASSAY	Sep 12, 1997	Substantially Equivalent	Diagnostic Reagents, Inc.
K881116	EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641	Jun 20, 1988	Substantially Equivalent	Diagnostic Systems
K853010	COBAS REAGENT FOR LIDOCAINE & CALIBRATORS	Aug 07, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K843184	STRATUS LIDOCAINE FLUOROMETRIC ENZYME	Sep 26, 1984	Substantially Equivalent	American Dade
K833381	VALPROIC ACID ANALYTICAL TEST PACK	Dec 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K833379	LIDOCAINE ANALYTICAL TEST PACK ACA	Dec 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K833623	MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY	Dec 08, 1983	Substantially Equivalent	Syva Co.
K832799	MODIFICA- OF EMIT CAD LIDOCAINE ASSAY	Oct 14, 1983	Substantially Equivalent	Syva Co.
K831354	EMIT QST LIDOCAINE ASSAY	May 27, 1983	Substantially Equivalent	Syva Co.
K823887	ADVANCE EMIT CAD DISOPYRAMIDE ASSAY	Jan 28, 1983	Substantially Equivalent	Syva Co.
K823866	ADVANCE EMIT CAD LIDOCAINE ASSAY	Jan 12, 1983	Substantially Equivalent	Syva Co.
K822347	LIDOCAINE FLUORESCENT IMMUNOASSAY	Aug 25, 1982	Substantially Equivalent	American Diagnostic Corp.
K802131	CYBREX LIDOCAINE	Oct 31, 1980	Substantially Equivalent	Abbott Laboratories
K801204	EMIT DISOPYRAMIDE ASSAY	Jun 09, 1980	Substantially Equivalent	Syva Co.