FDA Okays Complete Blood Cell Count Test

The U.S. Food and Drug Administration (FDA) cleared the XW-100 Automated Hematology Analyzer, a complete blood cell count (CBC) test that can be used in more health-care settings – including physicians’ offices and clinics – and by a wider range of support staff than available testing methods. The test also delivers faster results.

“A CBC is one of the most common physician-ordered tests. … 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,” said 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. “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.”

The FDA’s decision was based on data from a study conducted on 582 blood samples (from patients 2-92 years of age) that compared results collected from the XW-100 Automated Hematology Analyzer by non-medical personnel in CLIA-waived settings and those collected from a hematology analyzer in an accredited clinical laboratory. The study found that accurate testing can be effectively conducted by untrained personnel.

The device works by using a blood sample to classify and quantify 12 hematology parameters, and the test is intended for patients two years or older who require a whole blood cell count and white blood cell differential. The test can be used with other clinical and laboratory findings to provide information on conditions such as severe anemia and agranulocytosis; however, it is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases.

The device received premarket clearance and a CLIA waiver.

Source: U.S. Food and Drug Administration news release, November 6, 2017.