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510(k) Data Aggregation

    K Number
    K991473
    Device Name
    SIRSCAN
    Date Cleared
    1999-11-23

    (210 days)

    Product Code
    Regulation Number
    866.2850
    Why did this record match?
    Product Code :

    KZK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the results of susceptibility tests in other media can be keved in manually. The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated results reports, reqularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results. In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates: compares patient histories: classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics. SIRSCAN can be connected to any laboratory management system, as well as to some micro-dilution systems (e.g., Vitek™, Microscan™).
    Device Description
    SIRSCAN is an automatic reader of petri dishes that is used to manage overall susceptibility tests. The SIRSCAN is an automated susceptibility reader and interpretation system. It consists of two components: (1) The SIRSCAN automated zone reader device is a video-camera image analysis computer-based system to read susceptibility test data from NCCLS M2-A6 Kirby-Bauer disk-diffusion test plates for the following organisms: enterobacteriacae; staphylococci, (except coagulase negative staphylococci with weak growth); and non-fermenting gram negative bacilli (except strains with weak growth). Other susceptibility tests on solid medium are read with the electronic caliper, and the results of susceptibility tests in other media can be keyed in manually. (2) The SIRSCAN data management system compiles data from the NCCLS agar disk diffusion test. It prints, files and produces integrated results reports, regularly or on request, to be used by clinicians, bacteriologists and epidemiologists. Its expert system feature offers consistency checks for validation of tests and results. In addition, the SIRSCAN data management system: interprets zones; calculates MICs; provides quality control and epidemiology and infection control; identifies and eliminates duplicates; compares patient histories; classifies and monitors resistance phenotypes; monitors multi-resistant organisms; detects and monitors nosocomial infections; and prepares epidemiological statistics. SIRSCAN can be connected to any laboratory management system, and to some micro-dilution systems (e.g., VitekTM, MicroscanTM).
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