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    K Number
    K963800
    Device Name
    IL SYNTHESIS
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1996-11-13

    (51 days)

    Product Code
    CHL,CEM,CGA,CGZ,GFK,GLY,JFP,JGS
    Regulation Number
    862.1120
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K955793,K801848
    Why did this record match?
    Reference Devices :

    with Glucose Analyzer K955793, IL 682 CO-Oximeter K945677/S2, Radiometer ICA2 Ionized Calcium Analyzer K801848

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

    The IL Synthesis (hardware, software, and reagents) is for the quantitative in vitro diagnostic determination of pH, pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen), sodium (Na+), potassium (K+), calcium (Ca++), chloride (C1-), glucose (Glu), and Hematocrit (conductivity) in whole blood or pCO2 (partial pressure of carbon dioxide), pO2 (partial pressure of oxygen) in expired gases by direct ion selectrode (ISE) petentiometry. Sodium and potassium results are used to monitor electrolyte balance. Note that the number of electrodes is limited and any given instrument will only contain two of the three functions: calcium (Ca++), chloride (Cl-) and Glucose (Glu).

    The IL Synthesis (hardware, software, and reagents) also permits the quantitative in vitro diagnostic determination of five forms of hemoglobin in whole blood samples, total hemoglobin (tHb), oxyhemoglobin (%O2Hb), carboxyhemoglobin (%COHb), methemoglobin (MetHb) and reduced hemoglobin, also called deoxyhemoglobin (%RHb) and will also calculate the following parameters: oxygen content of hemoglobin (O ct) oxygen binding capacity (O2 cap) and oxygen saturation (sO2m).

    The IL Synthesis is designed for laboratory use to provide both measured and calculated results for blood gases, electrolytes, substrates, and co-oximeters on blood and gas samples.

    Device Description

    The IL Synthesis is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers. Its technology combines that of the IL BGElectrolytes Analyzer (IL 1400/1430) and the IL BGGE Blood Gas with Glucose Analyzer (IL 1660) with an integrated co-oximeter module - The IL Synthesis will be available in several different configurations of blood gas, electrolytes. co-oximeter, and glucose.

    AI/ML Overview

    Here's an analysis of the provided text regarding the IL Synthesis device, categorized by your requests.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state acceptance criteria in terms of specific performance thresholds that the device must meet (e.g., pH %CV must be

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