Product Code: LCD FDA class 2 21 CFR 862.3450

Enzyme Immunoassay, Gentamicin

Clinical Toxicology

Enzyme immunoassay for gentamicin is a laboratory test system used in clinical toxicology to quantify serum levels of gentamicin, an aminoglycoside antibiotic with a narrow therapeutic window requiring routine monitoring to prevent nephrotoxicity and ototoxicity. It is FDA Class 2, requiring 510(k) premarket clearance. The product code is LCD, 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

Unique Applicants

Years Active

Basic Information

Product Code: LCD
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 37 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243500	ARCHITECT iGentamicin	Jul 09, 2025	Substantially Equivalent	Abbott Laboratories
K102699	ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS	Apr 01, 2011	Substantially Equivalent	Abbott Laboratories
K060709	MULTIGENT GENTAMICIN	Jun 15, 2006	Substantially Equivalent	Seradyn, Inc.
K042479	VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE	Jan 06, 2005	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K020704	ROCHE ONLINE GENTAMICIN	Jul 12, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K012978	RANDOX GENTAMICIN	Sep 18, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K012311	IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)	Aug 20, 2001	Substantially Equivalent	Diagnostic Products Corp.
K010984	EMIT 2000 GENTAMICIN PLUS ASSAY	Apr 20, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K962819	GENTAMICIN FLEX REAGENT CARTRIDGE	Sep 13, 1996	Substantially Equivalent	Dade Intl., Inc.
K962519	EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS	Sep 04, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K953020	ACS GENTAMICIN	Aug 02, 1995	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K943982	IL TEST GENTAMICIN CALIBRATORS	Jan 25, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K935376	AXSYM GENTAMICIN	Jun 21, 1994	Substantially Equivalent	Abbott Mfg., Inc.
K940376	QMS GENTAMICIN ASSAY	Jun 02, 1994	Substantially Equivalent	Seradyn, Inc.
K913470	CEDIA(R) GENTAMICIN ASSAY	Sep 27, 1991	Substantially Equivalent	Microgenics Corp.
K904305	DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD	Oct 15, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K903743	IL GENTAMICIN ASSAY SYSTEM	Sep 17, 1990	Substantially Equivalent	Instrumentation Laboratory CO
K900703	MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR	Apr 12, 1990	Substantially Equivalent	Innotron of Oregon, Inc.
K895484	STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.	Oct 04, 1989	Substantially Equivalent	Baxter Healthcare Corp
K893912	TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD	Aug 21, 1989	Substantially Equivalent	Technicon Instruments Corp.
K874703	EMIT CONVENIENCE PACK: GENTAMICIN ASSAY	Dec 18, 1987	Substantially Equivalent	Syva Co.
K873855	EMIT QST GENTAMICIN ASSAY	Oct 29, 1987	Substantially Equivalent	Syva Co.
K873854	EMIT GENTAMICIN ASSAY	Oct 28, 1987	Substantially Equivalent	Syva Co.
K871329	EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640	May 12, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862260	EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS	Nov 03, 1986	Substantially Equivalent	Syva Co.
K860868	TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN	Apr 03, 1986	Substantially Equivalent	Technicon Instruments Corp.
K860045	DETERMINATION OF GENTAMICIN	Jan 22, 1986	Substantially Equivalent	Clinical Data, Inc.
K852672	ACA GENTAMICIN TEST PACK	Aug 02, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K850060	DU PONT GENTAMICIN ASSAY REAGENTS	Jan 18, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832445	STRATUS GENTAMICIN FLUOROMETRIC ENZYM	Aug 31, 1983	Substantially Equivalent	American Dade
K832056	EMIT AMD GENTAMICIN ASSAY	Aug 08, 1983	Substantially Equivalent	Syva Co.
K831416	EMIT QST TOBRAMYCIN ASSAY	Jun 08, 1983	Substantially Equivalent	Syva Co.
K831304	EMIT QST GENTAMICIN ASSAY	Jun 02, 1983	Substantially Equivalent	Syva Co.
K823387	SOPHEIA GENTAMICIN EIA KIT	Dec 22, 1982	Substantially Equivalent	Diagnostic Products Corp.
K811692	GENTAMICIN REAGENT TEST KIT	Jul 15, 1981	Substantially Equivalent	Beckman Instruments, Inc.
K811744	VIRGO IPA FOR DETECTION OF GENTAMICIN	Jul 10, 1981	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K800150	EMIT TOBRAMYCIN ASSAY	Feb 05, 1980	Substantially Equivalent	Syva Co.