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    K Number
    K171642
    Device Name
    Atellica IM Ferritin Assay
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2017-08-31

    (90 days)

    Product Code
    DBF
    Regulation Number
    866.5340
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    k041133,k992157
    Why did this record match?
    Device Name :

    Atellica IM Ferritin Assay

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

    The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and lithium heparin) using the Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.

    Device Description

    The Atellica Ferritin Assay kit includes the following components: Lite Reagent: 5.0 mL/reagent pack. Contains Goat polyclonal anti-ferritin antibody (~0.64 µg/mL) labeled with acridinium ester in HEPES buffer; protein stabilizers; sodium azide (

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the Atellica IM Ferritin Assay, based on the provided document:

    Acceptance Criteria and Reported Device Performance

    CriteriaAcceptance CriteriaReported Device Performance
    PrecisionCLSI EP05-A3 guidelines (Evaluation of Precision Performance of Quantitative Measurement Methods)Repeatability (Within-run): CV ranges from 1.2% to 3.5% for samples (4.2 ng/mL to 1453.6 ng/mL) and 1.2% to 1.6% for controls (51.8 ng/mL to 374.0 ng/mL).
    Within-Lab (Total Imprecision): CV ranges from 4.0% to 7.2% for samples and 4.5% to 5.5% for controls.
    Linearity/Assay Reportable RangeCLSI EP06-A (linearity of Quantitative Measurement Procedures). Implied: Acceptable percentage difference between observed and predicted values.The linearity data supports an analytical measuring range of 0.9 - 1650 ng/mL.
    Predicted % Difference (Y-Ŷ)/Ŷ*100: values ranged from -8.88% to 9.47% (excluding the lowest observed value of 0.20 ng/mL which was
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