Product Code: LCR FDA class 2 21 CFR 862.3900

Fluorescent Immunoassay, Tobramycin

Clinical Toxicology

Fluorescent immunoassay for tobramycin is a laboratory test system using fluorescence detection to quantify tobramycin serum concentrations in patients on aminoglycoside antibiotic therapy, where monitoring is required to maintain therapeutic levels and avoid nephrotoxic and ototoxic effects. FDA Class 2 classification applies, requiring 510(k) premarket clearance. The product code is LCR, regulated under 21 CFR 862.3900, in the Clinical Toxicology specialty. Third-party review is available.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LCR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LCR
Device Class: FDA class 2
Regulation Number: 862.3900
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

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
K060998	QMS TOBRAMYCIN	Jul 21, 2006	Substantially Equivalent	Seradyn, Inc.
K974029	ACS TOBRAMYCIN	Feb 12, 1998	Substantially Equivalent	Chiron Diagnostics Corp.
K962818	TOBRAMYCIN FLEX REAGENT CARTRIDGE	Sep 13, 1996	Substantially Equivalent	Dade Intl., Inc.
K952568	BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT	Aug 08, 1995	Substantially Equivalent	Beckman Instruments, Inc.
K911940	OPUS(R) TOBRAMYCIN	Jul 01, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K911613	VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4	Jun 28, 1991	Substantially Equivalent	Exmoor Plastics , Ltd.
K854873	INTRAOCULAR PRESSURE REDUCER	Feb 04, 1986	Substantially Equivalent	Mira, Inc.
K850058	DU PONT TOBRAMYCIN ASSAY REAGENTS	Jan 18, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K840847	IMMPULSE TOBRAMYCIN ASSAY REAGENTS	Apr 04, 1984	Substantially Equivalent	Paragon Diagnostics, Inc.
K832408	STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM	Aug 26, 1983	Substantially Equivalent	American Dade
K822197	NEEDLE HOLDERS	Aug 16, 1982	Substantially Equivalent	Kelleher Corp.
K821542	VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA	Jun 03, 1982	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K820130	ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY	Feb 05, 1982	Substantially Equivalent	Syva Co.
K813542	TOBRAMYCIN FLUORESCENT IMMUNOASSAY	Jan 12, 1982	Substantially Equivalent	American Diagnostic Corp.
K810941	AMES TDA TOBRAMYCIN TEST	Apr 17, 1981	Substantially Equivalent	Miles Laboratories, Inc.
K802668	CYBREX TOBRAMYCIN	Nov 24, 1980	Substantially Equivalent	Abbott Laboratories
K801308	FIAX TEST KIT FOR TOBRAMYCIN QUANTITA	Jun 20, 1980	Substantially Equivalent	Intl. Diagnostic Technology