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510(k) Data Aggregation

    K Number
    K093645
    Device Name
    EXL ANEM CAL, MODEL RC640
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2010-03-05

    (100 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k071224
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ANEMIA CAL is an in vitro diagnostic product for the calibration of the LOCI Vitamin B12 (B12)and LOCI Folate(FOL) methods on the Dimension(r) EXI(tm) integrated chemistry system and the Ferritin(FERR) method on the Dimension(r) clinical chemistry system.

    Device Description

    ANEMIA CAL is a multi-analyte, liquid, frozen bovine serum albumin based product containing ferritin from human liver, Vitamin B12 and Folate

    AI/ML Overview

    The provided text describes a 510(k) summary for an "Anemia Calibrator" device. However, it does not contain any information about acceptance criteria, device performance results from a study, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

    The document focuses on:

    • Manufacturer and device identification: Siemens Healthcare Diagnostics, Anemia Calibrator, Class II device.
    • Intended Use: Calibration of Ferritin (FERR), LOCI Vitamin B12 (B12), and LOCI Folate (FOL) methods on the Dimension® EXL™ integrated chemistry system and Dimension® clinical chemistry system.
    • Substantial Equivalence: Comparison to a predicate device (Dimension Vista® LOCI 4 Calibrator), highlighting similarities (intended use, form, constituents, traceability, levels, stability) and differences (system compatibility).
    • FDA Clearance Letter: Official notification of substantial equivalence determination.

    Therefore, I cannot provide the requested information. The input document simply does not contain the details necessary to answer those points.

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