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510(k) Data Aggregation

    K Number
    K052826
    Device Name
    QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
    Manufacturer
    SERADYN INC.
    Date Cleared
    2005-12-23

    (79 days)

    Product Code
    LBZ
    Regulation Number
    862.3320
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QMS® Quinidine assay is intended for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers.

    The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy.

    Device Description

    The QMS® Quinidine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.

    In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS® Quinidine Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.

    The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the The absorbance of unknown samples can be interpolated from the absorbance values of the drug, calibration curve and the concentration of the drug present in the sample can be calculated.

    The assay consists of reagents R1: anti-quinidine monoconal and R2: quinidine-oated microparticles. A six-level set of QMS® Quinidine Calibrators (A throu

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the QMS® Quinidine assay, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance CriteriaReported Device Performance
    Accuracy (% Recovery)100% ± 10%Mean Percent Recovery: 97.71% (for spiked samples)
    Linearity (R²)Not explicitly stated as a numerical AC, but implied good linearity0.9995 (correlation coefficient for linear regression)
    Sensitivity (LDD)Claim of 0.2 µg/mL supportedAverage LDD: 0.09 µg/mL
    Assay RangeBased on Accuracy, Linearity, Sensitivity0.2 to 8.0 µg/mL
    Precision (Total CV)
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