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510(k) Data Aggregation

    K Number
    K982603
    Device Name
    QUANTA LITE CHROMATIN ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-10-07

    (72 days)

    Product Code
    LLL
    Regulation Number
    866.5100
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An enzyme-linked immunosorbant assay (ELISA) for the semiquantitative detection of chromatin reactive antibodies In human serum. The presence of anti-chromatin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of drug-induced lupus (DIL) and systemic lupus erythematosus (SLE).

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ Chromatin ELISA device. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria, performance data, or details about the study design (sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a study report or a more detailed FDA submission.

    Therefore, I cannot directly answer your request using the provided text. The document focuses on the regulatory clearance based on substantial equivalence, not on a detailed presentation of performance data against acceptance criteria.

    To answer your request, I would need a different type of document, such as:

    • The 510(k) summary or full submission itself
    • A clinical study report
    • The device's Instructions For Use (IFU) or package insert, which often includes performance data.
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