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510(k) Data Aggregation

    K Number
    K183176
    Device Name
    Endotoxin Activity Assay (EAA)
    Manufacturer
    Spectral Medical Inc.
    Date Cleared
    2019-03-12

    (116 days)

    Product Code
    NGS
    Regulation Number
    866.3210
    Why did this record match?
    Product Code :

    NGS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EAA™ is a rapid in vitro diagnostic test that utilizes a specific monoclonal antibody to measure the endotoxin activity in EDTA whole blood specimens. The information, when used in conjunction with other clinical information and other relevant diagnostic tests aids in the risk assessment of patients in the ICU for progression to severe sepsis. Patients tested on their first day of admission to the ICU where the endotoxin activity (EA) value is ≥ 0.60, are three times more likely to develop severe sepsis within the next three days than subjects whose EA values are < 0.40 and should be closely monitored for such occurrence.
    Device Description
    Not Found
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    K Number
    DEN030002
    Device Name
    ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
    Manufacturer
    SPECTRAL DIAGNOSTICS, INC.
    Date Cleared
    2003-06-16

    (63 days)

    Product Code
    NGS
    Regulation Number
    866.3210
    Why did this record match?
    Product Code :

    NGS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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