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    K Number
    K171476
    Device Name
    SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
    Manufacturer
    Awareness Technology, Inc.
    Date Cleared
    2018-02-27

    (284 days)

    Product Code
    JGS,CEM,CGZ,JJE
    Regulation Number
    862.1665
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K961458
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    Device Name :

    SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

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

    The SelectaLyte™ Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in vitro diagnostic use only.

    The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

    The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

    The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    Device Description

    The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl) is an automated, microprocessor-controlled electrolyte analyzer for measurement of Sodium (Na*), and Chloride (Cl`) in serum, whole blood and QC aqueous solutions. The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl') utilizes ion selective electrodes (ISE) to measure test samples, and display the results automatically. The instrument features automatic and on-demand calibration, patient data storage, and interactive LCD touch screen.

    AI/ML Overview

    Acceptance Criteria and Device Performance for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

    The provided text details the performance evaluation of the SelectaLyte Electrolyte Analyzer as part of its 510(k) premarket notification. The acceptance criteria and the device's performance are primarily demonstrated through studies on precision, linearity, method correlation, and interference.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria values in table format (e.g., "CV must be

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