NEW YORK (360Dx) – The US Food and Drug Administration today provided CLIA waiver to Sysmex America's automated analyzer for common blood cell count.
The XW-100 Automated Hematology Analyzer was previously granted 510(k) clearance by the FDA in 2015 for use at the point of care. With the CLIA waiver, the test can be run in additional healthcare settings — including doctors' offices, clinics, and other healthcare facilities — and by a wider range of support staff, the FDA said.
A common blood cell count test is commonly used by physicians to assess patients' blood levels, determine if there is an infection, and if immediate intervention is required, Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health, said in a statement.
But currently, outside of a hospital environment, patients can wait at least 24 hours to get a CBC result when the test is performed by an off-site laboratory. "With the device cleared today, processing time may now be reduced by making testing available in those additional settings," St. Pierre said.
The XW-100 Automated Hematology Analyzer uses a blood sample to classify and quantify 12 different blood characteristics, providing patients with a blood component profile. It is intended for use on patients at least 2 years of age who require a whole blood cell count and white blood cell differential. Used with other clinical and laboratory findings, the test can alert clinicians that patients may have serious conditions, such as anemia or agranulocytosis, which require additional testing.
The analyzer is not intended for diagnosing or monitoring patients with primary or secondary hematologic disease, the FDA said, adding that CLIA waiver was granted after the agency determined it was substantially equivalent to the 2015 model and submitted data demonstrated the ease of use and low risk of false results when used by untrained operators.