Product Code: KLB FDA class 2 21 CFR 862.3900

Radioimmunoassay, Tobramycin

Clinical Toxicology

The Tobramycin Radioimmunoassay is an in vitro diagnostic test used in clinical toxicology laboratories to quantitatively measure tobramycin levels in patient serum, supporting therapeutic drug monitoring to ensure effective and safe dosing of this aminoglycoside antibiotic. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLB and it is regulated under 21 CFR 862.3900 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: KLB
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 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K060853	ONLINE TDM TOBRAMYCIN	Jun 09, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K012312	IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)	Aug 20, 2001	Substantially Equivalent	Diagnostic Products Corp.
K003341	EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS	Jan 22, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K904304	DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD	Oct 26, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K903192	IL TOBRAMYCIN ASSAY	Aug 22, 1990	Substantially Equivalent	Instrumentation Laboratory CO
K893913	TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD	Aug 21, 1989	Substantially Equivalent	Technicon Instruments Corp.
K882294	EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY	Jul 01, 1988	Substantially Equivalent	Syva Co.
K874223	EMIT TOBRAMYCIN ASSAY	Nov 13, 1987	Substantially Equivalent	Syva Co.
K854184	IN-VITRO TEST DETERMINATION OF TOBRAMYCIN	Dec 04, 1985	Substantially Equivalent	Clinical Data, Inc.
K852671	ACA TOBRAMY-CIN ANALYTICAL TEST PACK	Jul 22, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832763	TOBRAMYCIN REAGENT	Mar 23, 1984	Substantially Equivalent	Biosan Laboratories, Inc.
K832985	TOBRAMYCIN ANALYTICAL TEST PACK-ACA	Oct 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K822858	COAT-A-COUNT TOBRAMYCIN RIA KIT	Oct 18, 1982	Substantially Equivalent	Diagnostic Products Corp.
K813516	MRI TOBRAMYCIN RIA KIT	Dec 29, 1981	Substantially Equivalent	Microanalytic Research, Inc.
K812415	KALLESTAD ANTISERA TO TOBRAMYCIN	Sep 09, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.
K810597	MACRO-VUE CARD TEST	Mar 17, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K810011	GAMMA STICK 125-1 TOBRAMYCIN RIA KIT	Jan 28, 1981	Substantially Equivalent	Alpha Gamma Laboratory
K800743	TOBRAMYCIN RIA KIT	Apr 16, 1980	Substantially Equivalent	Antibodies, Inc.
K791596	FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY	Oct 17, 1979	Substantially Equivalent	Bio-Rad
K791502	QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO	Sep 04, 1979	Substantially Equivalent	Bio-Rad
K791435	AMES TDA/TOBRAMYCIN	Aug 16, 1979	Substantially Equivalent	Miles Laboratories, Inc.
K780934	IN VITRO TOBRAMYCIN RIA KIT	Aug 14, 1978	Substantially Equivalent	Clinical Assays, Inc.
K760967	TOBRAMYCIN RIA KIT	Dec 22, 1976	Substantially Equivalent	Diagnostic Products Corp.