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    K Number
    K160819
    Device Name
    Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
    Manufacturer
    THE BINDING SITE GROUP LTD.
    Date Cleared
    2016-06-16

    (84 days)

    Product Code
    OPX,OPY
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

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

    The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

    The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Lambda is used alongside Hevylite IgA Kappa to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, the Optilite Hevylite IgA Kappa Kit and Optilite Hevylite IgA Lambda Kit. It describes the intended use and regulatory classification, but it does not contain information about:

    • Acceptance criteria and reported device performance (in the context of a study demonstrating it meets the criteria)
    • Sample sizes for test sets, data provenance, training sets, or how ground truth was established for training sets
    • Number/qualifications of experts or adjudication methods for ground truth
    • MRMC comparative effectiveness studies or standalone algorithm performance

    Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.

    The document states the Indications for Use of the device, which are:

    • The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser.
    • The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser.
    • Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Kappa/IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations.
    • The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.

    This indicates the device's role in monitoring IgA multiple myeloma patients, but it does not specify performance metrics or the studies used to validate these claims.

    Summary of unavailable information from the given text:

    Question ItemInformation Not Available in Document
    1. Acceptance Criteria and Reported Performance TableNo acceptance criteria or performance data are presented in this FDA clearance letter.
    2. Test Set Sample Size and Data ProvenanceNot mentioned.
    3. Number and Qualifications of Experts for Test Set Ground TruthNot mentioned.
    4. Adjudication Method for Test SetNot mentioned.
    5. MRMC Comparative Effectiveness StudyNo mention of an MRMC study or effect size for human reader improvement with/without AI assistance (device is an IVD kit).
    6. Standalone Algorithm Performance StudyNot mentioned (device is an IVD kit, not an AI algorithm in the traditional sense).
    7. Type of Ground Truth Used (for any studies)Not mentioned.
    8. Training Set Sample SizeNot mentioned.
    9. How Ground Truth for Training Set EstablishedNot mentioned.
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