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    K Number
    K162399
    Device Name
    Atellica CH Magnesium (Mg)
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Date Cleared
    2017-01-19

    (146 days)

    Product Code
    JGJ
    Regulation Number
    862.1495
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    k861700
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    Device Name :

    Atellica CH Magnesium (Mg)

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

    The Atellica™ CH Magnesium (Mg) assay is for in vitro diagnostic use in the quantitative determination of magnesium in human serum, plasma (lithium heparin), and urine using the Atellica™ CH Analyzer. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

    Device Description

    The Atellica CH Mg assay is based on the modified xylidyl blue reaction, which was first described by C.K. Mann and J.H. Yoe. 1-2 The reagent was modified to eliminate the use of organic solvents. Magnesium ions react with xylidyl blue in an alkaline medium to form a water-soluble purple-red complex. The increase in absorbance of xylidyl blue at 505/694 nm is proportional to the concentration of magnesium in the sample. Calcium is excluded from the reaction by complexing with EGTA.

    AI/ML Overview

    This document describes the performance assessment of the Siemens Atellica CH Magnesium (Mg) assay, an in vitro diagnostic device used for the quantitative determination of magnesium in human serum, plasma, and urine.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by the performance characteristics demonstrated in the study and compared to the predicate device. The document does not explicitly list "acceptance criteria" as a separate column with pass/fail remarks, but rather presents the study results, implying that these results met the internal validation requirements for substantial equivalence.

    Performance CharacteristicAcceptance Criteria (Implicit, based on predicate/industry standards)Reported Device Performance (Atellica CH Magnesium (Mg))
    Detection LimitLoB meets protocol, LoD for serum/urine meets protocolLoB: 0.00 mg/dL, LoD: 0.02 mg/dL (serum), 0.04 mg/dL (urine)
    Limit of Quantitation (LoQ)Lowest sample concentration meets max allowable imprecision (5% CV) and bias (15%)Serum LoQ: 0.46 mg/dL (supports 0.50 mg/dL measuring interval) Urine LoQ: 0.57 mg/dL (supports 1.00 mg/dL measuring interval)
    Linearityp-values of nonlinear terms
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