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FDA clears complete blood cell count test with broad access
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The FDA today cleared the XW-100 Automated Hematology Analyzer for use in patients aged at least 2 years who require a whole blood cell count and white blood cell differential.
The XW-100 Automated Hematology Analyzer (Sysmex America, Inc) can be used in a variety of health care settings — including physicians’ offices, clinics or other health care facilities — by a range of personnel, enabling quicker access to results.
“A complete blood cell count [CBC] is one of the most common physician-ordered tests used to evaluate a patient’s blood levels, determine if an infection is present and if immediate intervention is needed,” 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 press release. “However, in the current health care setting, nonhospitalized 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. 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.”
Results from XW-100 Automated Hematology Analyzer — which uses a blood sample to classify and quantify 12 different blood parameters — can alert physicians to patients with severe anemia and agranulocytosis when combined with other clinical and laboratory findings. The test provides patients with a blood component profile as part of their overall health assessment.
However, the test cannot diagnose or monitor patients with primary or secondary hematologic diseases, including critically ill patients or those with cancer.
The FDA granted the test a waiver under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which allows the device to be used in a variety of nontraditional laboratory sites that have a CLIA Certificate of Waiver. More than 180,000 laboratories have this certification, according to CMS data.
The FDA reviewed the XW-100 Automated Hematology Analyzer through the dual submission pathway, which is a streamlined regulatory pathway for both marketing clearance, or 510(k) — a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device — and CLIA Waiver by Application.
The FDA originally cleared the XW-100 Automated Hematology Analyzer through the 510(k) pathway in 2015 for use at a patient’s point-of-care. To gain clearance for use in CLIA-waived settings with nonmedical personnel, this version of the analyzer provides simple instructions for action when results are outside of a specified range, and also reduces the number of blood parameters to 12.
FDA granted clearance and a CLIA waiver after determining the test was substantially equivalent to the 2015 model, with a low risk for false results when used by untrained operators.
A study conducted to evaluate 582 blood samples from patients aged 2 to 92 years showed results collected by nonmedical personnel in CLIA-waived settings lead to accurate testing when compared with use of a hematology analyzer in an accredited clinical laboratory.