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510(k) Data Aggregation

    K Number
    K981592
    Device Name
    ACS:CENTAUR AFP
    Manufacturer
    CHIRON DIAGNOSTICS CORP.
    Date Cleared
    1998-07-07

    (64 days)

    Product Code
    LOQ
    Regulation Number
    866.6010
    Why did this record match?
    Product Code :

    LOQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of ACS:Centaur AFP Immunoassay is for the quantitative determination of alpha-fetoprotein (AFP) in the following: - human serum and in amniotic fluid from specimens obtained at 15 to 20 weeks gestation, * as an aid in detecting open neural defects (NTD) when used in conjunction with ultrasonography and amniography testing, - human serum, as an aid in managing non-seminomatous testicular cancer when used in * conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Chiron Diagnostics ACS:Centaur Automated Chemiluminescence System.
    Device Description
    The Chiron Diagnostics ACS:Centaur AFP immunoassay is a two-site immunoassay using direct chemiluminometric technology, which uses constant amounts of two antibodies. The first antibody, in the Lite Reagent, is a purified polyclonal rabbit anti-AFP antibody labeled with acridinium ester. The second antibody, in the Solid Phase, is a monoclonal mouse anti-AFP antibody covalently coupled to paramagnetic particles. A direct relationship exists between the amount of AFP present in the patient sample and the amount of relative light units (RLU's) detected by the system.
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