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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#).

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.

Here's an analysis of the provided text, focusing on acceptance criteria and the study used to demonstrate them for the VEGA™ Hematology Analyzer.

The document describes the VEGA™ Hematology Analyzer and its performance characteristics through clinical studies conducted at three university hospital sites. The studies aimed to demonstrate the precision and accuracy of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" but presents performance metrics (reproducibility and linearity claims) that serve as de-facto acceptance criteria against the reported actual performance. For accuracy, the R² values indicate correlation with predicate devices, which can be interpreted as demonstrating acceptable performance against established methods.

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