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510(k) Data Aggregation

    K Number
    K061107
    Device Name
    DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
    Manufacturer
    THERMO ELECTRON OY
    Date Cleared
    2006-08-08

    (110 days)

    Product Code
    CEM,CFR,CGZ,JGS,JIX,JJE,JJY
    Regulation Number
    862.1600
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247

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

    The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated random access analyzers for in-vitro diagnostic use with clinical laboratory assays validated for use on these instrument platforms, including an ISE unit with Na+, K+ and CI- electrodes.

    The DPC T60 Glucose (HK) test system with associated Calibrators and Controls is intended for quantitative in-vitro diagnostic determination of glucose in serum or plasma using the DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoqlycemia, and of pancreatic islet cell carcinoma.

    The DPC ISE Micro Volume Chloride, Potassium and Sodium Electrodes with associated Calibrators are intended for quantitative in-vitro diagnostic determination of Chloride, Potassium and Sodium in serum or plasma using the DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers.

    Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

    Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

    Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

    Device Description

    The DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzers are fully automated random access analyzers for in-vitro diagnostic use with clinical laboratory assays validated for use on these instrument platforms, including an ISE unit with Na+, K+ and CI- electrodes.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a clinical chemistry analyzer. It does not contain any information about acceptance criteria or a study proving device performance as requested in your prompt.

    Specifically, the document:

    • Identifies the device (DPC T60i and DPC T60i Kusti Clinical Chemistry Analyzer and associated assays).
    • States its intended use (in-vitro diagnostic determination of glucose, chloride, potassium, and sodium in serum or plasma).
    • Declares substantial equivalence to a predicate device.
    • Outlines general regulatory requirements.

    It does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or information about training sets.
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