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510(k) Data Aggregation

    K Number
    K133582
    Device Name
    HEMOSIL D-DIMER HS 500 CONTROL
    Manufacturer
    INSTRUMENTATION LABORATORY
    Date Cleared
    2014-08-15

    (267 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HemosIL D-Dimer HS 500 Controls are assayed, human-sourced controls intended for the quality control of the HemosIL D-Dimer HS 500 assay as performed on the ACL TOP Family System, in a clinical laboratory setting. The controls are intended for in vitro diagnostic use.

    Level 1 D-D HS 500 Control is intended for the assessment of the assay around the clinical cutoff for VTE (500 ng/mL FEU).

    Level 2 D-D HS 500 Control is intended for the assessment of precision and accuracy of the assay at abnormal D-Dimer levels (above the cut-off).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter for the HemosIL D-Dimer HS 500 Controls, outlining its intended use and regulatory information. It does not contain details about specific performance studies, sample sizes, ground truth establishment, or expert reviews.

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