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510(k) Data Aggregation

    K Number
    DEN190056
    Device Name
    ADVIA Centaur Enhanced Liver Fibrosis (ELF)
    Date Cleared
    2021-08-20

    (603 days)

    Product Code
    Regulation Number
    862.1622
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ADVIA Centaur® Enhanced Liver Fibrosis (ELF™) is for in vitro diagnostic use in the determination of an ELF score based on the combined quantitative measurements of hyaluronic acid, amino-terminal propeptide of type III procollagen, and tissue inhibitor of matrix metalloproteinase 1 in human serum using the ADVIA Centaur XP system. ADVIA Centaur ELF is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH), to assess the likelihood of progression to cirrhosis and liver-related clinical events.
    Device Description
    The ADVIA Centaur ELF test contains the following: Reagents: Lite Reagent and Solid Phase reagents for HA, PIIINP and TIMP-1, and Ancillary Well reagents for HA and PIIINP are contained within ReadyPack® reagent packs. Each ReadyPack reagent cartridge has a barcode label used to automatically transfer information to the instrument when loaded into the instrument. Calibrators: ADVIA Centaur ELF Calibrator kit contains 2 levels of calibrators (Low and High). Calibration is performed using Low and High Calibrators of known value (as per the Calibrator Assigned Value card provided in the ELF Calibrator kit). Controls: The ADVIA Centaur ELF QC kit contains 3 controls (Level 1, Level 2, Level 3).
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