NEW YORK – CytoChip said Tuesday that it has secured US Food and Drug Administration 510(k) clearance and CLIA waiver for a complete blood count (CBC) testing system that can be used in point-of-care settings.
The Irvine, California-based firm said that its cartridge-based CitoCBC test and automated hematology analyzer are used for disease diagnosis, therapy monitoring, and routine health screening.
The benchtop analyzer is used to analyze blood samples in disposable cartridges and report the results of 16 hematology parameters, an FDA decision summary said. Those results are comprised of the CBC parameters of white blood cell count, red blood cell count, platelet count, hemoglobin concentration, hematocrit, and mean corpuscular volume as well as five-part white blood cell differential counts and percentages for neutrophil, lymphocyte, monocyte, eosinophil, and basophil.
CytoChip said that the CitoCBC Analyzer offers five-part differential CBC with a turnaround time of eight minutes.
"Achieving CLIA waiver for a CBC test is a major step forward in improving access to diagnostics at the point of care," CytoChip CEO Wendian Shi said in a statement.
The firm said that it is also seeking CE marking to market its CitoCBC test system in select EU countries.