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    K Number
    K033185
    Device Name
    COBAS INTEGRA ALP IFCC GEN.2
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2003-10-14

    (13 days)

    Product Code
    CJE
    Regulation Number
    862.1050
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K981897
    Why did this record match?
    Device Name :

    COBAS INTEGRA ALP IFCC GEN.2

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contain an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

    Device Description

    The COBAS Integra ALP IFCC Gen.2 is a colorimetric assay for the determination of the catalytic activity of alkaline phosphatase in serum or plasma in accordance to the recommended reference method of the International Federation of Clinical Chemists (IFCC). In the presence of magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by phosphatases into phosphate and p-nitro-phenol. The p-nitro-phenol released is directly proportional to the catalytic ALP activity.

    AI/ML Overview

    This is an in vitro diagnostic device for quantitative determination, not an AI/ML device. The request asks for details specific to AI/ML device studies that are not applicable here. However, I can still extract the acceptance criteria and the summary of the study proving the device meets them based on the provided text, focusing on performance characteristics relevant to an IVD.

    Here's the summary:

    1. Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria / Performance CharacteristicReported Device Performance (COBAS Integra ALP IFCC Gen.2)
    Intended UseQuantitative determination of catalytic activity of alkaline phosphatase in human serum and plasma for diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
    MethodColorimetric assay in accordance with the recommended reference method of the International Federation of Clinical Chemistry (IFCC).
    Sample TypeSerum, Heparin plasma
    Measuring Range2 - 1200 U/L
    Expected Values (at 37° C)Adults: Females: 35 - 104 U/L, Males: 40 - 129 U/L
    Children: 1 day:
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