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510(k) Data Aggregation

    K Number
    K130090
    Device Name
    STA COMPACT MAX
    Manufacturer
    DIAGNOSTICA STAGO, INCORPORATED
    Date Cleared
    2013-02-12

    (29 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTICA STAGO, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STA Compact Max® is a fully automatic clinical analyzer designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
    Device Description
    Diagnostica Stago's STA Compact Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA Compact® analyzer (K093167). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. The device consists of a cuvette, a metal ball, three needles, oscillation amplitude detection, a light source and sensor, and software.
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    K Number
    K093001
    Device Name
    STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
    Manufacturer
    DIAGNOSTICA STAGO, INCORPORATED
    Date Cleared
    2009-12-18

    (81 days)

    Product Code
    JPA
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTICA STAGO, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
    Device Description
    The STA-R Evolution® Expert Series Hemostasis System is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, support for instrument maintenance, and work load optimization. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples.
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