FDA Approves New CLIA-Waived CBC Test for Faster Results

Megan Brooks


November 07, 2017

The US Food and Drug Administration (FDA) has cleared a complete blood cell count (CBC) test that can be run in more healthcare settings, including physicians' offices, clinics, or other types of healthcare facilities, by a wider range of nonmedical support staff.

The XW-100 Automated Hematology Analyzer (Sysmex America, Inc) received premarket clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver.

A CBC is one of the most common physician-ordered tests used to evaluate a patient's blood to see 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 FDA's Center for Devices and Radiological Health, said in an FDA news release.

"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," St. Pierre said.

The XW-100 Automated Hematology Analyzer was originally cleared through the 510(k) pathway in 2015 for use at the patient's point of care. To support its use in CLIA-waived settings with nonmedical personnel, the analyzer provides simple instructions on what the test operator should do when results are flagged or fall outside of a specified range, the FDA explains. "To further ensure accurate testing in this setting and to eliminate results that are most susceptible to inaccuracy or require additional testing, the number of hematology parameters has been reduced to 12," it notes.

The FDA said it granted clearance and the CLIA waiver after it determined that the test was "substantially equivalent to the 2015 model and that the submitted data demonstrated the test's ease of use and low risk of false results when used by untrained operators."

The FDA reviewed data from a study conducted on 582 samples collected from patients aged 2 to 92 years. The study compared the XW-100 test results collected by nonmedical personnel in CLIA-waived settings to a hematology analyzer in an accredited laboratory. The results showed that by following the manufacturer's instructions for use, "accurate testing can be effectively conducted by untrained personnel," the FDA said.

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