FDA Clears Blood Cell Count Test

FDA www.fda.gov granted premarket clearance to Sysmex America Inc. www.sysmes.com for their XW-100 Automated Hematology Analyzer capable of doing a Complete Blood Cell Count (CBC). This technology produces much faster results since the CBC could be used by a wider range of support staff located in more healthcare settings.

Sysmex America’s XW-100 expected to be shipped in 2018, will make it possible for the most frequently requested blood tests to be conducted in more of the approximately 80,000 U.S medical practices where patients are first treated. Today only 32 percent of primary care facilities offer on-site testing while others send blood work to outside laboratories.

“The problem has been that in the current healthcare setting, non-hospitalized patients who require a CBC count can experience at least a 24 hour wait for test results and perhaps longer when the test is performed by an off-site lab,” said Donald St. Pierre, Acting Director of the Office of in Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Now, Blood tests will be available in as few as three minutes”.

The XW-100 is intended for use in patients two years and older who require a whole blood cell count and white blood cell differential. The device works by using a sample to classify and quantify 12 different blood characteristics (Hematology parameters) which can provide patients with a blood component profile as part of their overall health assessment.

Test results can be used with other clinical and laboratory findings to provide early alerts for patients with serious conditions such as severe anemia (low red blood cell or hemoglobin count) and agranulocytosis (low white blood cell count). However, it is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases including oncology and critically ill patients.

The device was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The CLIA waiver for this device allows it to be used by a variety of non-traditional laboratory sites. Which includes physicians’ offices, clinics, or other types of healthcare facilities with a CLIA Certificate of Waiver.

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