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    K Number
    K971614
    Device Name
    QUANTA LITE RF IGM
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-06-20

    (49 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    K083080,K102673,K190088
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A semiquantitative enzyme linked immunoassay for use in screening n Beaugust for IgM rheumatoid factor (RF) antibodies. Detection of pacitires IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a diagnostic test kit, not a study report for an AI-powered device. Therefore, the requested information regarding acceptance criteria, study design, and AI-specific metrics cannot be extracted from the provided text.

    The document discusses:

    • Device Name: QUANTA Lite™ RF IgM Test Kit
    • Regulatory Class: II
    • Product Code: DHR
    • Indications For Use: A semiquantitative enzyme-linked immunoassay for use in screening for IgM rheumatoid factor (RF) antibodies. Detection of specific IgM antibodies is an aid in the diagnosis of rheumatoid arthritis (RA).
    • Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.

    The text does not contain any details about clinical studies, acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy), sample sizes for test sets, ground truth establishment, expert involvement, or any information related to AI or machine learning performance.

    To answer your questions, a separate study report or clinical trial summary for the QUANTA Lite™ RF IgM Test Kit would be needed.

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