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510(k) Data Aggregation

    K Number
    K981328
    Device Name
    QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-06-19

    (67 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT

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

    An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3). This test is to be used in conjunction with other clinical findings to aid in the assessment of certain autoimmune vasculitides such as Wegener's granulomatosis.

    Device Description

    An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3).

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "QUANTA Lite™ PR3 IgG". This letter approves the marketing of the device, but it does not contain the acceptance criteria or the study details proving the device meets those criteria.

    The letter primarily states that the device is "substantially equivalent" to previously marketed devices and outlines regulatory information for the manufacturer. It specifies the "Indications For Use" which describe what the device is intended for, but not how well it performs.

    Therefore, I cannot provide the requested information from this document. The document refers to a "510(k) premarket notification" which would contain the study data and acceptance criteria, but that is not included here.

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