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510(k) Data Aggregation

    K Number
    K192785
    Device Name
    OptiScanner® 5000 Glucose Monitoring System
    Manufacturer
    Optiscan Biomedical Corporation
    Date Cleared
    2020-02-05

    (128 days)

    Product Code
    LZF, PYV
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    LZF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use.
    Device Description
    The OptiScanner® 5000 Glucose Monitoring System ("OptiScanner") is an automated, bedside glucose monitoring device that quantitatively measures the concentration of glucose in the blood of patients in the Surgical Intensive Care Unit (SICU). In contrast to Point of Care (POC) glucose measuring devices that measure glucose using enzymatic techniques, the OptiScanner uses a direct, reagent-free, spectrophotometer method to quantify glucose. The system is comprised of the following three primary components: - OptiScanner Instrument - OptiScanner Transport Cart - OptiScanner Disposable Cartridge The Instrument is the primary hardware component that houses all electrical, mechanical, analytical, and power subsystems. This includes the integrated pump, spectrometer, and the user interface. For mobility and easy access, the Instrument is mounted onto the chassis of a transport Cart. The Cart, in addition to holding the Instrument, holds batteries, IV pole(s) and bar code scanner. The Cartridge is a disposable, single patient use, sterile component containing the fluid pathway through which the blood is sampled, stored, processed, and analyzed. The Cartridge is the only component of the OptiScanner system that contacts patient blood. Integrated into the cartridge are tubing sets that are used to connect to the patient and to a saline bag. The Cartridge also includes a syringe that is intended to be pre-filled with heparin by the user for processing the blood samples. The Cartridge is inserted into the Instruments interface port that provides connections integrating the fluidic components of the Cartridge with the electro-mechanical subsystems of the Instrument.
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    K Number
    K162042
    Device Name
    OptiScanner 5000 Glucose Monitoring System
    Manufacturer
    OPTISCAN BIOMEDICAL CORP.
    Date Cleared
    2017-10-16

    (448 days)

    Product Code
    LZF, PYV
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    LZF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use.
    Device Description
    The OptiScanner® 5000 Glucose Monitoring System ("OptiScanner") is an in-line, automated, bedside, frequent, automated glucose monitoring system that quantitatively measures the concentration of glucose in the blood of patients in a Surgical Intensive Care Unit (SICU). In contrast to Point of Care (POC) glucose measuring devices that measure glucose using enzymatic techniques, the OptiScanner uses a direct, reagent-free, spectrophotometer method to quantify glucose. The system is comprised of the following three (3) primary components: - OptiScanner Instrument - OptiScanner Transport Cart - OptiScanner Disposable Cartridge The Instrument is the primary hardware component that houses all electrical, mechanical, analytical, and power subsystems. This includes the integrated pump, spectrometer, and the user interface. For mobility and easy access, the Instrument is mounted onto the chassis of a transport Cart. The Cart, in addition to holding the Instrument, holds batteries, IV pole(s) and a bar code scanner. The Cartridge is a disposable, single patient use, sterile component containing the fluid pathway through which the blood is sampled, stored, processed, and analyzed. The Cartridge is the only component of the OptiScanner system that comes in contact with patient blood. Integrated into the cartridge are tubing sets that are used to connect to the patient and to a saline bag. The Cartridge also includes a syringe that is pre-filled with heparin by the user for processing the blood samples. The Cartridge is inserted into the Instruments interface port that provides connections integrating the fluidic components of the Cartridge with the electromechanical sub-systems of the Instrument.
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    K Number
    K011238
    Device Name
    RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM
    Manufacturer
    METRACOR TECHNOLOGIES, INC.
    Date Cleared
    2002-01-08

    (260 days)

    Product Code
    LZF
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    LZF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K951739
    Device Name
    PUMP/BLOOD CHEMISTRY MONITOR
    Manufacturer
    VIA MEDICAL CORP.
    Date Cleared
    1996-02-28

    (320 days)

    Product Code
    LZF
    Regulation Number
    880.5725
    Why did this record match?
    Product Code :

    LZF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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