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Sysmex hematology analyzer gets CLIA waiver

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Nov. 21, 2017Sysmex received FDA approval for its XW-100 automated hematology analyzer as a CLIA-waived product. The CLIA waiver for this device allows it to be used by a variety of nontraditional laboratory sites, including physicians’ offices, clinics, or other CLIA-waived health care facilities.

The XW-100 is intended for use in patients two years of age and older who require a whole blood cell count and white blood cell differential. Test results can be used with other clinical and laboratory findings to provide early alerts of patients with serious conditions who require additional testing. It is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill patients. The analyzer provides testing results for 12 parameters.

“A CBC is one of the most common physician-ordered tests used to evaluate a patient’s blood levels, determine if an infection is present and if immediate intervention is needed. However, in the current health care setting, non-hospitalized patients who require a CBC can experience at least a 24-hour wait for test results, if not longer, when the test is performed by an off-site laboratory,” Donald St. Pierre, acting director of the office of in vitro diagnostics and radiological health in the FDA’s Center for Devices and Radiological Health, said in a statement. “This waiting period may be detrimental to the health of patients whose care depends on quick results to rule out conditions that may require immediate medical intervention. With the device cleared today, processing time may now be reduced by making testing available in these additional settings.”

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