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510(k) Data Aggregation

    K Number
    K011043
    Device Name
    OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
    Manufacturer
    Date Cleared
    2001-11-30

    (239 days)

    Product Code
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JXA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K981084
    Device Name
    URISCREEN
    Date Cleared
    1998-10-07

    (196 days)

    Product Code
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JXA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Uriscreen is a non-quantitative rapid screen for the detection of Urinary Tract Infection. Uriscreen detects both bacteria and/or white blood cells, common indicators of Urinary Tract Infection. Uriscreen is a non-quantitative rapid screen, which detects catalase. Urinary catalase may be associated with White Blood Cells, bacteria and other cells, some of which may be indicators of urinary tract infection. Only Adults should use the test.
    Device Description
    Uriscreen - Uriscreen is a rapid screen for the detection of Urinary Tract Infection. Uriscreen detects Catalase activity. Most organisms that commonly cause Urinary Tract Infection are Catalase positive. Additionally, Catalase activity is an indicator of white blood cells in urine. White blood cells are a common indicator of Urinary Tract Infection. Uriscreen tubes contain a reagent powder, which enables Catalase detection. Urine is added to the tube to the line indicated, a few drops of hydrogen peroxide solution are added. Production of foam indicates Catalase activity. Catalase activity is indicative of bacteria and/or white blood cells in the urine. Most bacteria that commonly cause urinary tract infection are Catalase positive. The presence of bacteria and/or white blood cells in the urine are clearly indicative of Urinary Tract Infection.
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    K Number
    K972676
    Device Name
    URINE SCREENING DEVICE
    Date Cleared
    1998-02-23

    (222 days)

    Product Code
    Regulation Number
    866.2660
    Why did this record match?
    Product Code :

    JXA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bactis 160US is an automated, computer assisted, optically based in vitro diagnostic instrument intended for the rapid detection and enumeration of bacteria in urine specimens. Urine samples are stained, filtered through a membrane, and excited with light of a defined wavelength range so as to produce a distinct fluorescent signal. Using fluorescent microscopy and a CCD camera, the image of the sample is captured. Using digitized image processing, the microscopic images are analyzed and the concentration of bacteria present in the specimen is determined by applying a proprietary software algorithm. The Bactis 160US is indicated for rapid urine screening for the purpose of determining the occurrence of bacteriuria. Evidence of bacteriuria is an important factor for clinicians to consider in making a diagnosis of urinary tract infection.
    Device Description
    The Bactis 160US is based on direct screening of urine using optical image analysis. Thirty (30) ul of well-mixed urine is mixed with fluorescent stains that bind to bacteria and other particles present in the specimen. The stained samples are filtered through a membrane. The dispersed and stained organisms are excited with a filtered lamp to produce a distinct fluorescent signal. Using fluorescence microscopy and a CCD camera the image of the sample is captured. These microscopic images are then analyzed. Using digitized image processing techniques, the bacteria are localized and enumerated, and their concentration is determined. Bacterial concentration for each specimen can be then reported. Alternatively, the concentration can be compared to a predetermined threshold (according to each laboratory's policy) and each urine sample can be categorized according to the infection category of "positive" or "negative". This method provide results within 25 minutes. The Bactis system is comprised of the following main components: - Control and Data Management System (CMS) 1. - Specimen Processor and Analyzer (SP&A) Unit 2. The urine screening process is controlled and monitored by the operator via the CMS, The CMS is comprised of two PC computers. An optional printer can be used to provide diagnostic reports. In the SP&A Unit, the specimens are processed and analyzed.
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