BEUDAMED
    Product Code: OJQ FDA class 2 21 CFR 862.1163

    Cardiac Allograft Gene Expression Profiling Test System

    Cardiovascular

    The Cardiac Allograft Gene Expression Profiling Test System is an in vitro diagnostic multivariate index assay (IVDMIA) test service performed in a single laboratory that analyzes RNA gene expression profiles from peripheral blood mononuclear cells to aid in identifying heart transplant recipients with stable allograft function who have a low probability of moderate or severe acute cellular rejection at the time of testing, used alongside standard clinical assessment. Classified as FDA Class 2 under regulation 21 CFR 862.1163 within the Cardiovascular medical specialty, it requires a 510(k) premarket notification. The product code is OJQ. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    15

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    Basic Information

    Product Code
    OJQ
    Device Class
    FDA class 2
    Regulation Number
    862.1163
    Medical Specialty
    Cardiovascular
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    In vitro diagnostic multivariate index assay (ivdmia) test service, performed in a single laboratory, for assessing the gene expression profile of rna isolated from peripheral blood mononuclear cells (pbmc) and indicated for use 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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K221640 AlloMap Heart Molecular Expression Testing
    DEN080007 ALLOMAP MOLECULAR EXPRESSION TESTING

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.