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510(k) Data Aggregation

    K Number
    K060998
    Device Name
    QMS TOBRAMYCIN
    Manufacturer
    SERADYN, INC.
    Date Cleared
    2006-07-21

    (101 days)

    Product Code
    LCR
    Regulation Number
    862.3900
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k802668
    Why did this record match?
    Device Name :

    QMS TOBRAMYCIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Seradyn QMS® Tobramycin assay, based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    TestAcceptance CriteriaReported Device Performance
    Accuracy% Recovery: 100 ± 10%Mean Percent Recovery: 94.14%
    Linearity% Recovery: 100 ± 10%Correlation coefficient (R²): 0.9996
    PrecisionTotal CV:
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