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510(k) Data Aggregation

    K Number
    K011662
    Device Name
    MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    2001-07-30

    (62 days)

    Product Code
    DDG
    Regulation Number
    866.5880
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This assay is designed for the in vitro measurement of human transferrin in serum using the Minineph®.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) notification for "Minineph® a-1 Transferrin Antiserum" does not contain information regarding:

    • Acceptance criteria and device performance table
    • Sample size and data provenance for a test set
    • Number of experts and their qualifications for ground truth establishment
    • Adjudication method for the test set
    • Multi-reader multi-case (MRMC) comparative effectiveness study
    • Standalone algorithm performance
    • Type of ground truth used
    • Sample size for the training set
    • How ground truth for the training set was established

    This document is primarily a clearance letter confirming substantial equivalence to a predicate device and outlining the indications for use. It does not delve into the detailed study design, performance data, or ground truth methodologies that would typically be found in a more comprehensive clinical or analytical validation report.

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