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510(k) Data Aggregation

    K Number
    K020414
    Device Name
    QUANTA LITE CCP ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2002-04-29

    (81 days)

    Product Code
    NHX
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QUANTA Lite™ CCP IgG ELISA is a semi-quantitative enzyme-linked immunosorbent assay for the detection of IgG anti-CCP (Cyclic Citrullinated Peptide) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the QUANTA Lite™ CCP IgG ELISA device. It approves the device as substantially equivalent to a legally marketed predicate device.

    However, the document does not contain specific information about:

    • Acceptance criteria for device performance
    • Detailed study design or results
    • Sample sizes for test or training sets
    • Data provenance or expert qualifications
    • Adjudication methods
    • MRMC comparative effectiveness studies
    • Standalone algorithm performance
    • Ground truth establishment methods

    Therefore, I cannot provide the requested table or answer the specific questions related to the study design and acceptance criteria from the given extract. The document mainly serves as a regulatory approval notice.

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