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510(k) Data Aggregation

    K Number
    K023824
    Device Name
    ALBUMIN COBALT BINDING TEST (ACB TEST)
    Manufacturer
    ISCHEMIA TECHNOLOGIES, INC.
    Date Cleared
    2003-02-14

    (88 days)

    Product Code
    NJV
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISCHEMIA TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Albumin Cobalt Binding Test (ACB® Test) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin. Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndromes (ACS) in low risk patients.
    Device Description
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