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    K Number
    K030655
    Device Name
    HOLOTC RIA
    Manufacturer
    AXIS-SHIELD BIOCHEMICALS, ASA
    Date Cleared
    2004-01-29

    (332 days)

    Product Code
    CDD,JIS,JJX
    Regulation Number
    862.1810
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K993571
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K993571

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

    The Axis-Shield HoloTC RIA is an in-vitro diagnostic assay for quantitative measurement of holotranscobalamin (vitamin B12 bound to transcobalamin) in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin B12 deficiency. HoloTC RIA is calibrated with HoloTC Calibrators. HoloTC controls are assayed for the verification of the accuracy and precision of the HoloTC RIA.

    Device Description

    The Axis-Shield HoloTC RIA is a competitive binding immunoassay in which a specific monoclonal antibody is used to capture transcobalamin from the patient sample. Thereafter the procedure is as commonly used in vitamin B12 assays. The cobalamin (vitamin B12) is released from the transcobalamin using dithiothreitol and sodium hydroxide. The released cobalamin (vitamin B12) then competes for a limited amount of intrinsic factor with added 'Co labelled vitamin B12. The Axis-Shield HoloTC RIA differs from the predicate device in two main aspects:

      1. The use of a transcobalamin specific antibody, this allows the quantitation of only the cobalamin bound to the protein transcobalamin as opposed to measurement of cobalamin bound to all proteins in the predicate device and
      1. The detection signal is radioactivity (37Co) as opposed to chemiluminescence in the predicate device.
    AI/ML Overview

    Here's an analysis of the provided text regarding the Axis-Shield HoloTC RIA device, addressing your requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria for all performance metrics. However, where implicitly stated or inferable, they are included.

    Performance CharacteristicAcceptance Criteria (Implicit/Explicit)Reported Device Performance
    Method ComparisonClose linear correlation, ideally slope ≈ 1, intercept ≈ 0, high r²HoloTC pmol/L = 0.55 * VB12-2 pmol/L; r² = 0.52 (compared to predicate Bayer Advia Centaur VB12 assay)
    Reference Intervaln/a (established for diagnosis)37-171 pmol/L (95% central interval for Finnish population, n=303)
    External Evaluation (CV)
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