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510(k) Data Aggregation

    K Number
    K972608
    Device Name
    RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    1997-08-04

    (54 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RANDOX ASSAYED SPECIFIC PROTEIN CONTROL

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

    The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.

    The Randox Specific Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

    Device Description

    The Randox Laboratories Limited Specific Protein Control Serum (Low and Elevated) are based on lyophilised human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly specific protein analysis. These control materials are available at two constituent concentrations.

    AI/ML Overview

    I am sorry, but the provided text from the FDA letter (K972608) refers to a RANDOX Assayed Specific Protein Control, which is a control material used for clinical chemistry applications. It is not a medical device that uses AI or requires the extensive studies (like MRMC, standalone performance, training sets, etc.) typically associated with AI-powered devices.

    The document is an FDA clearance letter stating that the device is "substantially equivalent" to previously marketed devices. It does not contain information on:

    • Acceptance criteria and reported device performance in the context of an AI study.
    • Sample sizes for test sets or training sets.
    • Data provenance.
    • Number of experts and their qualifications for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone performance studies.
    • Type of ground truth used (pathology, outcomes data, etc.).
    • How ground truth for a training set was established.

    Therefore, I cannot fulfill your request for details about acceptance criteria and studies using AI, as this information is not present in the provided document, which pertains to a different type of medical product.

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