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510(k) Data Aggregation

    K Number
    K051122
    Device Name
    ITAG MHC TETRAMER CMV ASSAY
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2005-08-01

    (91 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    K153538
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Beckman Coulter's iTAg MHC Tetramer-CMV is for the identification and enumeration of cytomegalovirus (CMV) -specific CD8+ lymphocytes in whole blood by flow cytometry, and for the assessment of CMV-specific immune status in immunosuppressed stem cell transplant recipients. The assay is limited to individuals with the following HLA types: A0101, A0201, B0702, B0801, B*3501.

    Device Description

    iTAg™ MHC Tetramer CMV is similar to existing CD (cluster differentiation) technology, measuring subsets of an individual's total leukocyte population. The tetramer kits include five tetramers specific for particular CD3+CD8+ cell receptors. While 5 alleles are provided for this assay, an individual's analysis may use up to 4 of these 5 tetramers. Tetramers enumerate CD3+CD8+ subsets by flow cytometry, similar to antibodies: Same specimen (whole blood), indication (identification and enumeration of lymphocyte populations), platform (flow cytometry), fluorochromes, Flow-Count Fluorospheres, and accessory reagents. The assay components include: Vials of anti-CD8 FITC, Vials of anti-CD4 PE, Vials of anti-CD3 PC5, Vials of Flow-Count Beads, Vials of lysing agent, Vials of fixative, Up to 5 vials of individual Tetramers labeled with PE, Vials of negative Tetramer labeled with PE.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the iTAg MHC Tetramer-CMV device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance MetricAcceptance Criteria (Implied)Reported Device Performance
    SpecificityNo significant interference from common interferents.No significant interference from common interferents (Monocytes, granulocytes, platelets, red blood cells). No significant interference from similar viral response (EBV). Tetramers were specific for identified alleles.
    Linear RangeAcceptable correlation between expected and actual values.Deming regression analysis showed acceptable correlation. Upper limit varied by allele (119 to >300 cells/µL).
    Accuracy and RecoveryAcceptable recovery for cells/µL and % tetramer positive.All tetramers demonstrated acceptable recovery. Overall percent recovery across three tetramers was 96%.
    Analytical SensitivityDefined lower limit of detection.1.0 cell/µL for absolute counts. 0.2% tetramer positive.
    ReproducibilityAcceptable CV ranges for intra- and inter-laboratory testing.Intra-laboratory: 1.3% CV to 16.3% CV.
    Inter-laboratory (Beckman Coulter facilities): 0.9% CV to 13.3% CV.
    Inter-laboratory (Beckman Coulter + two external sites): 2.6% CV to 29.6% CV.
    Instrument ComparisonComparable results and interchangeability between specified flow cytometers; acceptable correlation.BD FACSCalibur vs. BCI EPICS-XL (Absolute Counts): Comparable results, interchangeable. Deming regression: y = 0.9697x - 0.3255, r = 0.9978.
    BD FACSCalibur vs. BCI EPICS-XL (% Tetramer Positive): Comparable results, interchangeable. Deming regression: y = 0.9800x - 0.0152, r = 0.9982.
    BCI FC500 vs. BCI EPICS-XL (Absolute Counts): Comparable results, interchangeable. Deming regression: y = 0.9812X + 0.1527, r = 0.9921.
    BCI FC500 vs. BCI EPICS-XL (% Tetramer Positive): Comparable results, interchangeable. Deming regression: y = 1.0426X - 0.0448, r = 0.995.
    Imprecision (Absolute Counts): Comparable between instruments, averaged
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