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510(k) Data Aggregation

    K Number
    K153538
    Device Name
    Dextramer CMV Kit
    Manufacturer
    Immudex Aps
    Date Cleared
    2017-03-02

    (448 days)

    Product Code
    GKZ,COU
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K051122
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dextramer® CMV Kit is a semi-quantitative assay intended for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ T cells in anticoagulated (Na Heparin) whole blood specimens by flow cytometry.

    Dextramer® CMV Kit is indicated for assessment of CMV-specific immune status and risk of CMV reactivation in adult human stem cell transplant patients following immunosuppression and used in conjunction with other laboratory and clinical findings.

    The kit cannot be used to measure CMV infection or disease.

    The kit is limited to individuals with the following HLA types: A0101, A0201, B0702, B0801, B*3501.

    Special instrument requirements:

    FACSCanto II flow cytometer (Becton Dickinson).

    Device Description

    The Dextramer® CMV Kit comprises 5 CMV Dextramers, Negative control as well as 3 antibodies recognizing CD3, CD4, and CD8. The Dextramer® CMV Kit accurately enumerates CMV-specific T cells in blood samples. This involves a two-step procedure followed by analysis by flow cytometry:

    Step 1: Determination of the percentage of CMV-specific CD3CD8 T cells in the sample (Tube A)

    Step 2: Determination of the absolute number of CD3CD8 T-cells in the sample (Tube C)

    The absolute number of CMV-specific CD3CD8 T cells/ul blood is then determined.

    AI/ML Overview

    This document is a 510(k) summary for the Immudex Dextramer® CMV Kit, detailing its substantial equivalence to a predicate device and presenting performance characteristics from non-clinical and clinical studies.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in the traditional sense (e.g., a specific threshold that must be met for approval for each metric). Instead, it presents performance characteristics. For comparative studies, substantial equivalence based on statistical metrics (slope, intercept, r-value) is used. For clinical studies, a statistically significant risk ratio is the performance indicator.

    Performance CharacteristicAcceptance Criteria (Implicit)Reported Device Performance
    Non-clinical studies
    Analytical sensitivityLowest concentration measurable with acceptable CV% (e.g.,
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