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510(k) Data Aggregation

    K Number
    K022018
    Device Name
    RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
    Manufacturer
    RHIGENE, INC.
    Date Cleared
    2002-07-05

    (15 days)

    Product Code
    LJM
    Regulation Number
    866.5100
    Type
    Special
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560

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

    The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "RhiGene MESACUP ANA TEST" and confirms its substantial equivalence to a legally marketed predicate device. However, the document does not contain the specific information required to complete the table and answer the questions about acceptance criteria, study details, ground truth establishment, or sample sizes.

    The document is primarily an FDA clearance letter for a medical device (an in-vitro diagnostic test), and as such, it focuses on the regulatory determination of substantial equivalence rather than providing detailed study protocols or results.

    To fulfill the request, one would typically need access to the full 510(k) submission, which would include the performance data and the study's design.

    Therefore, I cannot provide the requested information based solely on the text provided.

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