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510(k) Data Aggregation

    K Number
    K163629
    Device Name
    Audit MicroControls Linearity FD Tumor Markers II
    Manufacturer
    Aalto Scientific, Ltd.
    Date Cleared
    2017-03-10

    (78 days)

    Product Code
    JJY, JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aalto Scientific, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Audit® MicroControls™ Linearity FD Tumor Markers II is intended to simulate human patient samples for use as assayed quality control material, determining linearity, callbration verification of reportable range for the HE4 and HER2 analytes. The Audit® MicroControlsTM Linearity FD Tumor Markers II is for In Vitro Diagnostic use only.
    Device Description
    The Audit® MicroControls™ Linearity FD Tumor Markers II is an in-vitro diagnostic device consisting of sets of 5 levels of freeze-dried, linearity material and additives in human based serum. The product contains the following analytes: HE4 and HER2. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
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    K Number
    K161874
    Device Name
    Audit MicroControls Linearity DROP LQ Blood Glucose
    Manufacturer
    AALTO SCIENTIFIC, LTD.
    Date Cleared
    2016-08-10

    (33 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALTO SCIENTIFIC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is intended to simulate human patient samples for use as assayed quality control material, determining linearity, calibration, and the verification of reportable range for the glucose analyte. The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is for In Vitro Diagnostic use only.
    Device Description
    The Audit® MicroControls™ Linearity DROP LQ Blood Glucose is an in-vitro diagnostic device consisting of sets of 5 levels of liquid, linearity material and additives in human based serum. The product contains the following analyte: glucose. Each set consists of 5 levels labeled Level A, B, C, D and E. Each level has a fill size of 1ml. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
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    K Number
    K143571
    Device Name
    Audit MicroControls Linearity LQ Cystatin-C
    Manufacturer
    AALTO SCIENTIFIC, LTD.
    Date Cleared
    2015-01-23

    (37 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    AALTO SCIENTIFIC, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Linearity LQ Cystatin-C is an assayed quality control material intended to simulate human patient samples for use in determining linearity, calibration, and the verification of reportable range for the Cystatin-C analyte. The Linearity LQ Cystatin-C is for In Vitro Diagnostic use only.
    Device Description
    The Audit® MicroControls™ Linearity LQ Cystatin-C product is an in-vitro diagnostic device consisting of one set of five levels of liquid, linearity/QC material. For the set there are five levels labeled A, B, C, D and E. The set contains 1ml for each level. The set contains the Cystatin-C analyte and additives in human and bovine based serum. Materials of human origin used in the manufacture of this linearity set have been tested using FDA approved methods and are found to be non-reactive for HbsAg and antibodies to HCV and HIV-1/2.
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