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510(k) Data Aggregation

    K Number
    K071562
    Device Name
    D3 HEMATOLOGY ANALYZER, MODEL D3
    Date Cleared
    2007-12-11

    (187 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    DREW SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DREW D3 Hematology Analyzer is a fully automated (microprocessor controlled) quantitative hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
    Device Description
    The D3 Hematology Analyzer is a stand-alone benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using the impedance & spectrophotometry techniques.
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    K Number
    K070704
    Device Name
    TRILOGY ANALYZER
    Date Cleared
    2007-07-13

    (122 days)

    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    DREW SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TRILOGY is a fully automated, discrete, software-driven, multi-purpose analyzer for spectrophotometric and potentiometric in vitro determination of analytes in body fluids. It is an open system intended for clinical use in a professional setting for use with various chemistry assays that may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. TRILOGY is intended for the quantitative determination of glucose, creatinine and urea nitrogen in serum. 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. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. Urea nitrogen measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. TRILOGY includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium, and chloride in serum and urine. These measurements are used to montor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.
    Device Description
    The TRILOGY Analyzer is a fully automated, multi-purpose analyzer used for analysis in clinical chemistry with optional ion selective electrode (ISE) module. The analyzer is intended for the in vitro measurement of various analytes in serum and urine. The analyzer incorporates robotics, computer and communication technology to perform integrated tasks from pipetting and diluting of patient specimens, assaying specimens in Routine or STAT modes, performing spectrophotometric, and potentiometric modes simultaneously and analyzing data using multiple curve-fitting parameters. The TRILOGY Analyzer is an open system for multiple disciplines including clinical chemistry and an optional ISE module.
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