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510(k) Data Aggregation

    K Number
    K150412
    Device Name
    Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
    Date Cleared
    2015-08-28

    (191 days)

    Product Code
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Optilite CH50 reagents are intended for the quantitative in vitro determination of total classical complement activity (CH50) in human serum using the Binding Site Optilite turbidimetric analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. This test should be used in conjunction with other laboratory and clinical findings. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals. The Optilite CH50 calibrator is intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals. The Optilite CH50 controls are intended for use on the Optilite analyser in conjunction with the Binding Site Optilite CH50 Reagent (product code NK095.OPT) for the determination of total complement activity. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
    Device Description
    Not Found
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    K Number
    K113349
    Device Name
    HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
    Date Cleared
    2012-07-11

    (240 days)

    Product Code
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Human CH50 reagent pack for use on the SPA plus. These reagents are intended for the quantification of total classical complement activity (CH50) in human serum on the Binding Site SPAPLUS analyser. Measurement of complement activity aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components. The test results are to be used in conjunction with clinical findings and other laboratory tests. Human CH50 calibrator set for use on the SPA plus The Human CH50 calibrator set is intended for use on the SPAPLUS in conjunction with the Binding Site Human CH50 reagent pack (product code: NK095.S) for the determination of total complement activity. Human CH50 controls for use on the SPA plus. The Human CH50 controls are intended for use in conjunction with the Binding Site Human CH50 reagent pack for use on the SPAPLUS (product code: NK095.S).
    Device Description
    Not Found
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    K Number
    K992488
    Device Name
    TOTAL HAEMOLYTIC COMPLEMENT RID KIT
    Date Cleared
    1999-09-17

    (53 days)

    Product Code
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For measuring human haemolytic complement activity by the Classical pathway in human serum, as an aid in the diagnosis of disease associated with complement activation, and with complement component deficiencies.
    Device Description
    Total Haemolytic Complement RID Kit
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    K Number
    K974111
    Device Name
    QUIDEL CH50 EQ EIA
    Manufacturer
    Date Cleared
    1998-07-29

    (271 days)

    Product Code
    Regulation Number
    866.5240
    Why did this record match?
    Product Code :

    DAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The QUIDEL CH50 Eq EIA intended to measure the total classical complement pathway activity in human serum, thereby allowing detection of a deficiency of one or more of the complement components C1 through C9. The QUIDEL CH50 Eq EIA is intended for laboratory and professional use.
    Device Description
    The QUIDEL CH50 Eq EIA provides a direct measure of the total classical complement activity in serum by quantifying the amount of TCC generated under standard conditions. The test uses a monoclonal antibody to a unique neoantigen to capture the TCC analyte. Since both the QUIDEL CH50 Eq EIA and the CH50 test rely on the generation of TCC and correlate, the QUIDEL CH50 Eq EIA's results are expressed in CH50 unit equivalents per milliliter.
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