(122 days)
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.
| Parameter | Acceptance Criteria (Stated Claim/Target) | Reported Device Performance (Worst Case Across Sites/Parameters, where applicable) |
|---|---|---|
| Reproducibility (CV%) | ||
| WBC |
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”