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510(k) Data Aggregation

    K Number
    K091975
    Device Name
    INTEGRATED LABORATORY AUTOMATION SOLUTION
    Date Cleared
    2010-03-10

    (252 days)

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

    INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Integrated Laboratory Automation Solution (ILAS) is designed to transport clinical patient samples to clinical laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and test orders to be performed by the laboratory analyzer. The patient specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each analyzer station to determine if tests are to be run and if so the specimen is switched to a side track supplying the analyzer with the specimen. The ILAS is an accessory to the Vitros 250 automated chemistry analyzer and other similar chemistry automated clinical analyzers. Automated clinical analyzers utilize various methods and technologies for the determination of numerous analytes, such as Glucose and other measurands that may be adaptable to each integrated analyzer. Glucose on the ILAS system is for the quantitative in vitro diagnostic measurement of Glucose in plasma. 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.
    Device Description
    The automation system (ILAS) is designed to transport clinical patient specimens (blood and urine) to the laboratory analyzers that perform the actual clinical tests. The ILAS system receives downloads from the Laboratory Information System (LIS) with the patient ID and menu of tests to be performed by the laboratory analyzers. The patients specimens are loaded onto the ILAS and bar codes are read. The bar codes are read at each laboratory analyzer station to determine whether the specimen should be directed to that specific analyzer. If a test is to be run on the analyzer, the specimen is switched to a side track supplying the testing analyzer with clinical specimens. All reporting of clinical specimen test results are transmitted from the analyzer to the LIS and the ILAS software is not involved in test results reporting.
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