IRIS Receives 510(k) for Body Fluids Analysis Using iQ 200 Analyzer
IRIS International, a manufacturer and marketer of automated in-vitro diagnostic urinalysis systems and medical devices used in hospitals and clinical reference laboratories, has received 510(k) clearance from the FDA to market its new Body Fluids Module for analyzing cerebrospinal and serous body fluids utilizing the company's iQ200 product platform.
From a technical standpoint, the Body Fluids Module enables the iQ200 analyzer and iQ200 Sprint high-speed platform to analyze cerebrospinal fluid (CSF) and serous fluids, such as peritoneal (abdominal), pericardial (heart) and pleural (lung), to examine and count red blood cells and nucleated cells. Nucleated cells are leukocytes and other tissue cells such as mesothelial and malignant cells.
By incorporating lysing of red blood cells into the body fluids analysis procedure, the iQ200 can provide a quantitative result for red blood cells and nucleated cells. Since the iQ200 takes digital images of all of the particles present, laboratory technicians can also note the presence of bacteria or crystals qualitatively in body fluids. The iQ200 is the only fully integrated and automated system in the world performing a complete urinalysis -- microscopy and chemistry combined.
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