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510(k) Data Aggregation

    K Number
    K080468
    Device Name
    LIASYS WITH MODELS LIASYS
    Manufacturer
    AMS S.R.L. ANALYZER MEDICAL SYSTEM
    Date Cleared
    2008-07-25

    (155 days)

    Product Code
    CFR,CDN,CEM,CGX,CGZ,CIT,JGS,JJE
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The "Liasys" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides the In Vitro diagnostic quantitative measurements for glucose, urea nitrogen, creatinine and AST in serum, and for sodium, potassium and chloride in scrum. Other various chemistry assays may be adaptable to this instrument.

    Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Urea Nitrogen measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Measurements of Creatinine are used in the diagnosis and treatment of muscle diseases and endocrine disorders. Aspartate amino transferase (AST) quantitative measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and 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.

    Device Description

    The "Liasys" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry.

    AI/ML Overview

    The provided text is a 510(k) premarket notification decision letter from the FDA for the Liasys device, a clinical analyzer for in vitro diagnostic quantitative measurements. It does not contain information about acceptance criteria or specific study details proving the device meets those criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, it does not include the detailed technical specifications or performance study results typically found in the submission itself.

    Therefore, I cannot provide the requested information based on the given input, as the study details are not present.

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