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510(k) Data Aggregation

    K Number
    K172173
    Device Name
    DiaSpect Tm, DiaSpect Tm Cuvettes
    Manufacturer
    EKF-diagnostic GmbH
    Date Cleared
    2018-04-06

    (261 days)

    Product Code
    GKR
    Regulation Number
    864.5620
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K081719
    Why did this record match?
    Device Name :

    DiaSpect Tm, DiaSpect Tm Cuvettes

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

    The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.

    Device Description

    The DiaSpect Tm system consists of an analyzer and cuvettes. The DiaSpect Tm analyzer is a spectrophotometric instrument for the total hemoglobin concentration in unaltered human blood. The DiaSpect Tm Cuvette is injection-molded of poly methyl methacrylate (PMMA) and contains a cavity of 10 uL volume. The cavity is empty.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study that proves the DiaSpect Tm system meets those criteria, based on the provided document:

    Acceptance Criteria and Reported Device Performance

    Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Precision/Reproducibility20-Day Precision: Total CV 0.95 and slope of linear equation within 1.0 ± 0.1 compared to reference method.Linearity: Correlation coefficient > 0.95 and slope (0.9837) was within 1.0 ± 0.1.
    Met criteria.
    Detection LimitsLoQ (Limit of Quantitation): To be determined based on specified Total Error.LoB (Limit of Blank): 0.0 g/dL
    LoD (Limit of Detection): 0.3 g/dL
    LoQ (Limit of Quantitation): 1.2 g/dL
    **Analytical Specificity
    (Interference)**Bias
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