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510(k) Data Aggregation

    K Number
    K112545
    Device Name
    QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2012-07-31

    (334 days)

    Product Code
    MOB,JIX,JJX,MVJ
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology (IM)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

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

    The QUANTA Flash PR3 is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-proteinase 3 (PR3) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash PR3 is an aid in the diagnosis of granulomatosis with polyangiitis (GPA) in conjunction with clinical findings and other laboratory tests.

    The QUANTA Flash PR3 Calibrators are intended for use with the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.

    The QUANTA Flash PR3 Controls are intended for quality control purposes of the QUANTA Flash PR3 chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-proteinase 3 (PR3) autoantibodies in human serum.

    The QUANTA Flash MPO is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash MPO is an aid in the diagnosis of microscopic polyangiitis (MPA) in conjunction with clinical findings and other laboratory tests.

    The QUANTA Flash MPO Calibrators are intended for use with the QUANTA Flash MPO chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.

    The QUANTA Flash MPO Controls are intended for quality control purposes of the QUANTA Flash MPO chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-myeloperoxidase (MPO) autoantibodies in human serum.

    The QUANTA Flash GBM is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum on the BIO-FLASH® instrument. QUANTA Flash GBM is an aid in the diagnosis of Goodpasture's Syndrome in conjunction with clinical findings and other laboratory tests.

    The QUANTA Flash GBM Calibrators are intended for use with the QUANTA Flash GBM chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.

    The QUANTA Flash GBM Controls are intended for quality control purposes of the QUANTA Flash GBM chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument that is used in the measurement of IgG anti-glomerular basement membrane (GBM) autoantibodies in human serum.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the QUANTA Flash® suite of autoantibody detection assays. It primarily outlines the indications for use for each reagent, calibrator, and control, and states that the devices are substantially equivalent to legally marketed predicate devices.

    The document does not contain the acceptance criteria or study details regarding the performance of the device. This type of information is typically found in the 510(k) submission summary or other supporting documentation, which is not provided in your input. The FDA clearance letter summarizes the regulatory decision, not the technical performance data that led to it.

    Therefore, requested information cannot be extracted from the provided text.

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