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510(k) Data Aggregation

    K Number
    K013643
    Device Name
    AUSAM TOTAL ALBUMIN ASSAY
    Manufacturer
    AUSAM BIOTECTHNOLOGIES INC
    Date Cleared
    2003-08-14

    (647 days)

    Product Code
    JIQ
    Regulation Number
    862.1645
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUSAM TOTAL ALBUMIN ASSAY

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

    The Total Intact Albumin Assay (also known as the AusAm Microalbumin Plus Urinary Assay) is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine. Measurement of intact albumin with this assay aids in the identification of patients who may warrant further testing for kidney or intestinal disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (AusAm Total Intact Albumin Assay). This type of document does not typically contain the detailed study information required to answer your specific questions about acceptance criteria, statistical methods, ground truth establishment, or sample sizes for device performance studies.

    The letter confirms substantial equivalence to a predicate device but does not present the underlying data or study methodology.

    Therefore, I cannot extract the information requested from the provided text. To answer your questions, one would need to access the actual 510(k) submission document or supporting studies.

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