Product Code: KLQ FDA class 2 21 CFR 862.3035

Radioimmunoassay, Amikacin

Clinical Toxicology

The Amikacin Radioimmunoassay is an in vitro diagnostic test that uses radiolabeled antibody methods to measure amikacin concentrations in patient serum, used in clinical toxicology settings for therapeutic drug monitoring of this aminoglycoside antibiotic. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLQ and it falls under 21 CFR 862.3035 in 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: KLQ
Device Class: FDA class 2
Regulation Number: 862.3035
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 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K052815	QMS AMIKACIN REAGENTS	Nov 01, 2005	Substantially Equivalent	Seradyn, Inc.
K033884	RANDOX AMIKACIN	Jun 09, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K955570	INNOFLUOR AMIKACIN ASSAY SYSTEM	Feb 09, 1996	Substantially Equivalent	Oxis Intl., Inc.
K903100	INNOFLUOR (TM) AMIKACIN REAGENT SET	Aug 09, 1990	Substantially Equivalent	Innotron of Oregon, Inc.
K894517	FPR AMIKACIN KIT	Sep 28, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K852317	COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR	Jun 25, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K843211	AMIKACIN ANALYTICAL TEST PACK ACA	Sep 12, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K841161	IMMPULSE AMIKACIN ASSAY REAGENTS	May 02, 1984	Substantially Equivalent	Paragon Diagnostics, Inc.
K840193	EMIT QST AMIKACIN ASSAY	Mar 23, 1984	Substantially Equivalent	Syva Co.
K832336	STRATUS AMIKACIN FLUOROMETRIC	Aug 31, 1983	Substantially Equivalent	American Dade
K822657	EMIT-AMD AMIKACIN ASSAY	Sep 28, 1982	Substantially Equivalent	Dade Behring, Inc.
K821771	MACRO-VUE CARD TEST, AMIKACIN	Jun 25, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K820781	COAT-A-COUNT AMIKACIN IRA	Apr 09, 1982	Substantially Equivalent	Diagnostic Products Corp.
K813541	AMIKACIN FLUORESCENT IMMUNOASSAY	Jan 12, 1982	Substantially Equivalent	American Diagnostic Corp.
K811026	AMES TDA TM AMIKACIN TEST	Apr 29, 1981	Substantially Equivalent	Miles Laboratories, Inc.
K802877	AMIKACIN RIA KIT	Dec 19, 1980	Substantially Equivalent	Antibodies, Inc.
K802669	CYBREX AMIKACIN	Nov 12, 1980	Substantially Equivalent	Abbott Laboratories
K801130	AMES TDA AMIKACIN	May 28, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K800517	TOBRAM E.R.A. TM	Mar 20, 1980	Substantially Equivalent	P-L Biochemicals, Inc.
K780494	AMIKACIN	Apr 10, 1978	Substantially Equivalent	Diagnostic Products Corp.