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510(k) Data Aggregation
K Number
K060998Device Name
QMS TOBRAMYCIN
Manufacturer
SERADYN, INC.
Date Cleared
2006-07-21
(101 days)
Product Code
LCR
Regulation Number
862.3900Why did this record match?
Product Code :
LCR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.
Device Description
The QMS® Tobramycin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the assay.
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K Number
K974029Device Name
ACS TOBRAMYCIN
Manufacturer
CHIRON DIAGNOSTICS CORP.
Date Cleared
1998-02-12
(112 days)
Product Code
LCR
Regulation Number
862.3900Why did this record match?
Product Code :
LCR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chiron Diagnostics ACS:180 Tobramycin Assay is for the quantitative determination of tobramycin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence Systems. Monitoring the patient's serum or plasma tobramycin levels is important both to ensure that the drug is present in therapeutic concentrations and to avoid toxicity.
Device Description
The Chiron Diagnostics ACS:180 Tobramycin assay is a competitive immunoassay using direct, chemilumenescent technology. Tobramycin in the patient sample competes with acradinium ester-labeled tobramycin in the Lite Reagent for a limited amount of monoclonal mouse anti-tobramycin antibody, which is covalently coupled to the paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of tobramycin present in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.
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K Number
K962818Device Name
TOBRAMYCIN FLEX REAGENT CARTRIDGE
Manufacturer
DADE INTL., INC.
Date Cleared
1996-09-13
(56 days)
Product Code
LCR
Regulation Number
862.3900Why did this record match?
Product Code :
LCR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TOBR FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
Device Description
The TOBR method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-tobramycin conjugate and tobramycin-specific monoclonal antibody.
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