Product Code: LCQ FDA class 2 21 CFR 862.3450

Fluorescent Immunoassay Gentamicin

Clinical Toxicology

Fluorescent immunoassay for gentamicin is a laboratory test system that uses fluorescence-labeled antibodies to measure serum gentamicin levels in patients receiving this aminoglycoside antibiotic, supporting therapeutic drug monitoring to prevent toxicity. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LCQ, regulated under 21 CFR 862.3450, in the Clinical Toxicology specialty. Third-party review eligibility applies.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: LCQ
Device Class: FDA class 2
Regulation Number: 862.3450
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 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972609	VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM	Aug 06, 1997	Substantially Equivalent	Bio-Rad
K955569	INNOFLUOR GENTAMICIN ASSAY SYSTEM	Feb 09, 1996	Substantially Equivalent	Oxis Intl., Inc.
K945523	COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS	Mar 09, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K943550	GENTAMICIN FPIA REAGENT SET AND CALIBRATORS	Nov 17, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K905721	OPUS GENTAMICIN	Feb 21, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K904226	'TDXFLX ANALYZER	Oct 29, 1990	Substantially Equivalent	Abbott Laboratories
K894523	FPR GENTAMICIN KIT	Sep 28, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K852158	BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA	Jun 25, 1985	Substantially Equivalent	Bioprobe Intl., Inc.
K852013	GENTAMICIN KIT(FPIA)	Jun 10, 1985	Substantially Equivalent	Windsor Laboratories, Inc.
K843827	COBAS REAGENTS FOR GENTAMICIN & CALIBRAT	Feb 01, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K841865	INNOFLOUR GENTAMICIN	May 31, 1984	Substantially Equivalent	Innotron Diagnostics
K841162	IMMPULSE GENTAMICIN ASSAY REAGENTS	May 02, 1984	Substantially Equivalent	Paragon Diagnostics, Inc.
K820285	SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY	Feb 18, 1982	Substantially Equivalent	Syva Co.
K813539	GENTAMICIN FLUORESCENT IMMUNOASSAY	Dec 31, 1981	Substantially Equivalent	American Diagnostic Corp.
K810942	AMES TDA GENTAMICIN TEST	Apr 17, 1981	Substantially Equivalent	Miles Laboratories, Inc.
K801867	DISPOSABLE MEDICATION NEBULIZER	Aug 20, 1980	Substantially Equivalent	Hospitax
K801084	CYBREX GENTAMICIN	May 23, 1980	Substantially Equivalent	Abbott Laboratories
K800032	FIAX TEST KIT FOR GENTAMICIN QUAN.	Jan 23, 1980	Substantially Equivalent	Intl. Diagnostic Technology
K782025	GENTAMICIN FLUROIMMUNASSAY KIT	Jan 26, 1979	Substantially Equivalent	Technia Diagnostics , Ltd.