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510(k) Data Aggregation

    K Number
    K172232
    Device Name
    LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600
    Manufacturer
    AMS Diagnostics
    Date Cleared
    2019-06-12

    (687 days)

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

    AMS Diagnostics

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

    The LIASYS 600 Electrolyte Measurement System is intended for the quantitative determination of sodium, chloride, and potassium in human serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of hormone aldosterone), diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    The LIASYS 600 creatinine reagent is intended for the quantitative determination of creatinine in human serum. Packaged for the ease of use with LIASYS 600. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

    The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

    Device Description

    The LIASYS 600 is a random access, computer controlled, standalone clinical analyzer intended for the in-vitro determination of analytes in human serum.

    AI/ML Overview

    This FDA document describes the clearance of the LIASYS 600 Electrolyte Measurement System and LIASYS 600 Creatinine reagent. It does not contain information about acceptance criteria or specific study results that proves the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for the specified indications for use.

    Therefore, I cannot provide the requested information based on the provided text. The document is a 510(k) clearance letter, which affirms substantial equivalence rather than detailing performance acceptance criteria and study findings.

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