FDA has cleared a complete blood cell count (CBC) analyzer that can be used in a wide range of healthcare settings, including physicians’ offices and clinics, and administered by a vast range of personnel, including support staff. According to the agency, the broadened test access may allow for faster availability of results.
“A 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,” says Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “However, in the current healthcare 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 offsite 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 recently cleared device, St. Pierre adds, “processing time may now be reduced by making testing available in these additional settings.”
The XW-100 automated hematology analyzer from Sysmex America Inc, Lincolnshire, Ill, is intended for use in patients 2 years of age and older who require a whole blood cell count and white blood cell differential. Test results can be used with other clinical and laboratory findings to provide early alerts about patients who require additional testing for such serious conditions as severe anemia and agranulocytosis. However, the analyzer is not intended to diagnose or monitor patients with primary or secondary hematologic diseases, including oncology and critically ill patients.
The device works by using a blood sample to classify and quantify 12 different blood characteristics, providing patients with a blood component profile as part of their overall health assessment. The device uses a 15 µL sample of venous blood to provide a CBC with a three-part white blood cell differential, offering 12 clinically useful results, all of which are available in as little as 3 minutes.
“The XW-100 is a breakthrough that will transform blood testing for patients and the healthcare professionals who treat them,” says Ralph Taylor, chief executive of Sysmex America. “In addition to making faster treatment plans possible, the technology will improve the efficiency of healthcare delivery.”
The XW-100 automated hematology analyzer was granted waived complexity categorization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The analyzer was reviewed through the dual submission pathway, a streamlined regulatory pathway for both premarket notification (510(k)) clearance and CLIA waiver by application. The system was originally cleared through the 510(k) pathway in 2015 for use at the patient’s point of care.
FDA reviewed data from a study conducted on 582 samples collected from patients ranging from 2 to 92 years old. The study compared the XW-100 test results collected by nonmedical personnel in CLIA-waived settings to a hematology analyzer in an accredited clinical laboratory. Study results showed that by following the manufacturer’s instructions for use, accurate testing can be effectively conducted by untrained personnel.
“The XW-100 is the culmination of our long journey to develop a high-quality hematology analyzer able to deliver accurate and reliable results in a CLIA-waived primary care setting,” says Andy Hay, chief operating officer of Sysmex America. “During that time, Sysmex made considerable investments in comprehensive testing and market acceptance studies, as well as in building a robust infrastructure and related systems to ensure the XW-100 safely serves healthcare professionals and the patients who depend on them.”
Sysmex expects to begin shipping the XW-100 in early 2018.