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510(k) Data Aggregation

    K Number
    K061730
    Device Name
    OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
    Manufacturer
    OSMETECH, INC.
    Date Cleared
    2006-08-04

    (45 days)

    Product Code
    CEM, CHL, GKR, GLY, JFP, JGS, JJY
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSMETECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osmetech OPTI R Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, total hemoglobin content and oxygen saturation in sample of whole blood, serum or plasma in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
    Device Description
    The OPTI R Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in., 10 lbs], microprocessor-based instrument using optical fluorescence for the measurement of pH, pCO2, PO2, sodium, potassium and ionized calcium in samples of whole blood, plasma or serum. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A multiple use cassette provides up to 50 patient and 42 aqueous quality control samples on a single cassette during a seven day period. The sample count and time is maintained by the analyzer and reported to the user with each sample operation. The cassette contains six optical fluorescence sensors and is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. One of these sensors, the oxygen sensor, is also used for the simultaneous measurements of ctHb and SO2. This bar code is read by 'swiping' the foil pouch through a bar code reader conveniently located on the right side of the OPTI R instrument. This bar coded information is used for a calibration verification of the cassette prior to sample introduction. The cassette is then removed from the pouch and placed into the measuring chamber of the OPTI R and a light-tight cover is closed and secured. The OPTI R performs a calibration as needed, but minimally every 30 minutes or within 30 minutes of every patient's sample utilizing liquid buffer and precision calibration gas, both of which are maintained within the analyzer. The buffer is contained in the OPTI R Fluid Pack and the precision gas is contained in a cylinder. Various checks of mechanical and calibration integrity are performed during this calibration to ensure correct operation and measurement. The OPTI R aspirates the specimen into the cassette either from a capillary tube, syringe or Osmetech ComfortSampler™, and into position over the fluorescence sensors for pH, PCO2, PO2, Na , K , and iCa " as well as ctHb and SO2. During this process, additional checks are made for position and integrity of the sample, measurement stability, and end-point. After the results are displayed and printed the sample is moved to the waste pouch contained within the OPTI R Fluid Pack. The cassette is then rinsed and calibrated, after which the cassette is ready for the next sample. Communication to the device is accomplished simply with the use of a touch screen graphical user interface. The analyzer communicates to the user through a color display and with a thermal printer using heat sensitive paper to output measured values, calibration reports, and other information. The data from the analyzer may be communicated to hospital HIS/LIS data systems through an RS232 output terminal.
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    K Number
    K052027
    Device Name
    OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200
    Manufacturer
    OSMETECH, INC.
    Date Cleared
    2005-09-29

    (64 days)

    Product Code
    CGZ, CEM, CHL, JFP, JGS, JJE
    Regulation Number
    862.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSMETECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of pH, sodium, potassium, ionized calcium, and chloride in samples of whole blood, serum, plasma and aqueous controls in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
    Device Description
    The OPTI LION Electrolyte Analyzer is a small [4.7 x 14.2 x 9.1 inches, 10 pounds}, microprocessor-based instrument using optical fluorescence for the measurement of pH, sodium, potassium, ionized calcium, and chloride and utilizes a graphical touch screen user interface. The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.
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