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510(k) Data Aggregation

    K Number
    DEN080007
    Device Name
    ALLOMAP MOLECULAR EXPRESSION TESTING
    Manufacturer
    Date Cleared
    2008-08-26

    (11 days)

    Product Code
    Regulation Number
    862.1163
    Why did this record match?
    Applicant Name (Manufacturer) :

    XDX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AlloMap Molecular Expression Testing is an In Vitro Diagnostic Multivariate Index assay (IVDMIA) test service, performed in a single laboratory, assessing the gene expression profile of RNA isolated from peripheral blood mononuclear cells (PBMC). AlloMap Testing is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment. Indicated for use in heart transplant recipients: - l 15 years of age or older - I At least 2 months (>55 days) post-transplant
    Device Description
    AlloMap Molecular Expression Testing is performed in a single laboratory (XDx Laboratories). Blood is drawn from the patient and subsequently processed, packaged and shipped frozen to the XDx Laboratory. At the XDx Laboratory, gene expression levels are determined via real time PCR for each of the test and control genes and converted to the AlloMap Test Score. The AlloMap Test Score is then reported to the physician.
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