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510(k) Data Aggregation

    K Number
    K120817
    Device Name
    QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2013-02-26

    (344 days)

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

    QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

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

    QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semiquantitative measurement of anti-cardiolipin (aCL) In human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings.

    The QUANTA Flash aCL IgA Controls are intended for quality control purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument.

    Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 ((S2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings.

    The QUANTA Flash $2GP1 IgA Controls are intended for the quality control purposes of the QUANTA Flash B2GP1 IgA assay performed on the BIO-FLASH® instrument.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or specific studies proving device performance. The document is a 510(k) premarket notification letter from the FDA, confirming substantial equivalence for QUANTA Flash™ B2GP1 IgA and QUANTA Flash™ aCL IgA devices and their controls. It outlines regulatory information and indications for use but does not detail performance metrics, study designs, sample sizes, or ground truth establishment.

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