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510(k) Data Aggregation

    K Number
    K111534
    Device Name
    ABACUS 3CP
    Manufacturer
    Date Cleared
    2012-08-02

    (427 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIATRON US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diatron Abacus 3CP System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM#, MID%, MID#, GRA%, GRA#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV in K3EDTA anti-coagulated venous whole blood samples. The Diatron Abacus 3CP is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
    Device Description
    The 'Abacus 3CP' is a fully automated, bench top hematology cell counter with a cap piercing function. It uses the impedance-method for counting cells passing through a small aperture, and measures the hemoglobin content of red blood cells using a photometric method. The analyzer features a color graphical LCD display module and a foil keypad of 29 keys including 6 software buttons, 6 function keys and a START button. The instrument allows printing reports to an external printer (USB port), or can have an optional built-in printer module. Its internal memory is capable of storing 1000 records with full histograms, and individual patient data. The QC measurements are stored in a separate database. The software operating the instrument can be updated by using a USB flash memory device. The instrument can be connected to a host computer for uploading records in its memory through a USB SLAVE port (USB B) or serial link (RS232). Archiving records to an USB flash memory device is also possible.
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    K Number
    K112755
    Device Name
    ABACUS 5
    Manufacturer
    Date Cleared
    2012-03-27

    (188 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIATRON US INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT and MPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
    Device Description
    The 'Abacus 5' is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical measurement technology. The 'Abacus 5' analyzer uses the impedance method for measurement of leukocytes (WBC), erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of the hemoglobin (HGB) content of red blood cells is accomplished by photometric measurement technology. Five part leukocyte differential (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished using optical laser-based flow cytometric technology. A vivid color touch screen display is featured with an intuitive, informative, and attractive user interface. A START button allows one-touch operation for ease of use. The 'Abacus 5' analyzer's unique software system supports the use of many commonly used external printers with its USB connections. The 'Abacus 5' internal database is capable of storing 100,000 patient, QC, and calibration result records including flags and graphical scatter diagrams and histograms. The system software is field-upgradeable to ensure up-to-date operation. An automatic optional Autosampler is available (sold separately) for automated processing of up to 100 sample tubes for increased laboratory efficiency. The 'Abacus 5' features advanced Ethernet LIS connectivity using the HL7 protocol in addition to standard serial interfaces, providing the clinical laboratory with flexible connectivity options.
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