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510(k) Data Aggregation

    K Number
    K981237
    Device Name
    QUANTA LITE RIBOSOME P ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-06-05

    (63 days)

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

    QUANTA LITE RIBOSOME P ELISA

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

    An enzyme linked immunosorbant assay (ELISA) for the semiquantitative detection of ribosome antibody in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) and other related connective tissue diseases.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance), or ground truth establishment. This document only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    Therefore, I cannot provide the requested information from the given text.

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