The FDA has granted premarket clearance and a waiver under the Clinical Laboratory Improvement Amendments of 1988 to Sysmex America for its complete blood cell count test.
Broadened access to the XW-100 automated hematology analyzer for patients at least 2-years-old in additional healthcare settings such as non-traditional laboratories, will allow for faster availability of results, the agency said.
The analyzer provides results from a complete blood count test more quickly than the standard 24-hour delivery.
