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510(k) Data Aggregation

    K Number
    K962633
    Device Name
    VEGA HEMATOLOGY ANALYZER
    Manufacturer
    ABX, INC.
    Date Cleared
    1996-11-04

    (122 days)

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

    ABX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VEGA™ Hematology Analyzer is a quantitative, automated in vitro diagnostic analyzer capable of performing the following twenty six (26) hematological parameters: white blood cells (leukocytes) -WBC, red blood cells (erythrocytes) -RBC, hemoglobin -HGB, hematocrit -HCT, mean corpuscular volume -MCV, mean corpuscular hemoglobin -MCH, mean corpuscular hemoglobin concentration -MCHC, red blood cell distribution width -RDW, platelets -PLT, plateletcrit -PCT, platelet distribution width -PDW, mean platelet volume -MPV, lymphocyte (number) -LYM#, lymphocyte (percent of WBC) -LYM%, monocyte (number) -MON#, monocyte (percent of WBC) -MON%, basophil (number) -BAS#, basophil (percent of WBC) -BAS%, neutrophil (number) -NEU#, neutrophil (percent of WBC) -NEU%, eosinophil (number) -EOS#, eosinophil (percent of WBC) -EOS%, Atypical Lymphocyte (number) -ALY#, Atypical Lymphocyte (percent of lymphocyte number) -ALY%, Large Immature cell (number) -LIC#, Large Immature cell (percent of WBC) -LIC%. Only twenty (20) parameter printout will be made available for diagnostic use in the United States (eliminating PCT, PDW, ALY%, ALY#, LIC%, LIC#).
    Device Description
    The VEGA™ Hematology Analyzer is a quantitative, automated in vitro diagnostic analyzer capable of performing twenty six (26) hematological parameters. It utilizes five (5) different reagents: VEGADIL™, VEGALYSE™, VEGACLEAN™, EOSINOFIX™, and BASOLYSE™. The counting principle for WBC, RBC, and PLT is based on impedance variation. HGB is measured by spectrophotometry. HCT is measured by a specialized electronic device that adds pulse heights. MCH, MCHC, and MCV are calculated indices. RDW is a coefficient of variation of RBC distribution. MPV is a platelet index. Leukocyte differential counts are performed using cytochemistry with Eosinofix™ reagent, impedance to measure volume, and optical transmission measurement to obtain information on the internal structure of the cells.
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