LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040958
    Device Name
    PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
    Manufacturer
    TOKYO BOEKI MEDICAL SYSTEM LTD.
    Date Cleared
    2005-02-15

    (308 days)

    Product Code
    JJE,CEM,CGZ,JGS,JIX
    Regulation Number
    862.2160
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K851172
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOKYO BOEKI MEDICAL SYSTEM LTD.

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

    This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.

    Device Description

    The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.

    AI/ML Overview

    Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested:

    Acceptance Criteria and Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided 510(k) summary for the Prestige 24i (and equivalent models) details performance characteristics. The acceptance criteria themselves are not explicitly stated as pass/fail thresholds in the document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (Roche Cobas Mira Plus) through correlation, linearity, and precision. The reported performance is presented to support this claim of equivalence.

    Given this, the table below presents the reported performance values. The implied acceptance criteria are that these values should be comparable to or within acceptable ranges for similar clinical chemistry analyzers for the measurement of sodium, potassium, and chloride, especially when compared to the predicate device.

    Performance CharacteristicAnalyteReported Device Performance (Prestige 24i)Implied Acceptance Criteria (Based on Substantial Equivalence)
    Correlation AnalysisCorrelation Coefficient (r): High (e.g., typically >0.95 for good agreement, though specific threshold not stated).
    Slope (Least-Squares): Close to 1.0 (indicating proportional agreement).
    Y-axis intercept: Close to 0 (indicating minimal constant bias). Values presented are considered acceptable for substantial equivalence.
    Sodiumr = 0.97, Slope = 0.95, Intercept = +6.8625 mmol/L
    Potassiumr = 0.99, Slope = 0.98, Intercept = -0.0135 mmol/L
    Chlorider = 0.98, Slope = 0.97, Intercept = +3.2579 mmol/L
    LinearityThe device should be linear over the clinically relevant range for each analyte; the reported ranges are considered acceptable.
    Sodium70 - 200 mmol/L (Serum)
    Potassium1 - 50 mmol/L (Serum)
    Chloride70 - 200 mmol/L (Serum)
    Precision (Within Run)Coefficient of Variation (%CV): Low (typically
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1