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510(k) Data Aggregation

    K Number
    K012340
    Device Name
    BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
    Manufacturer
    BAYER CORP.
    Date Cleared
    2001-10-01

    (69 days)

    Product Code
    JMO
    Regulation Number
    862.1415
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)

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

    The ADVIA IMS Unsaturated Iron Binding Capacity (UIBC) assay is an in vitro diagnostic device intended to measure iron binding capacity in human serum and dlagmostly are new inding capacity are used in the diagnosis and treatment of anemias.

    Device Description

    Not Found

    AI/ML Overview

    The provided document describes a 510(k) summary for a new in vitro diagnostic device, the ADVIA® IMS™ Unsaturated Iron Binding Capacity (UIBC) method. The summary focuses on demonstrating substantial equivalence to a predicate device, the Technicon CHEM 1. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state formal "acceptance criteria" in terms of predefined success thresholds (e.g., "CV must be

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