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510(k) Data Aggregation

    K Number
    K051646
    Device Name
    ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2005-10-07

    (108 days)

    Product Code
    JGS,CEM,CGZ
    Regulation Number
    862.1665
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

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

    This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are offen used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Pointe Scientific Inc. regarding their ISE Diluent, 1N KCL Internal Reference, and ISE standards Low and High. This document is a regulatory approval and does not contain the information requested about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot fulfill the request using the provided input. This document does not describe device performance or any studies conducted to evaluate it.

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