Product Code: LFW FDA class 2 21 CFR 862.3900

Fluorescence Polarization Immunoassay, Tobramycin

Clinical Toxicology

A fluorescence polarization immunoassay for tobramycin is a laboratory test that uses polarized light measurement to quantify tobramycin, an aminoglycoside antibiotic, in patient specimens for therapeutic drug monitoring and prevention of toxicity during treatment of serious bacterial infections. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LFW and is regulated under 21 CFR 862.3900 within the Clinical Toxicology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LFW
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 10 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K964670	ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN	Feb 04, 1997	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K944371	TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR	Nov 10, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K941614	AXSYM TOBRAMYCIN	Aug 18, 1994	Substantially Equivalent	Abbott Laboratories
K912143	CEDIA(R) TOBRAMYCIN ASSAY	Jul 26, 1991	Substantially Equivalent	Microgenics Corp.
K900707	MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR	Apr 20, 1990	Substantially Equivalent	Innotron of Oregon, Inc.
K894531	FPR TOBRAMYCIN KIT	Sep 01, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K872562	INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET	Aug 17, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K854392	TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU	Dec 05, 1985	Substantially Equivalent	Windsor Laboratories, Inc.
K843828	COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA	Feb 01, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K841866	INNOFLOUR TOBRAMYCIN	May 31, 1984	Substantially Equivalent	Innotron Diagnostics