"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. 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 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. With the device cleared today, processing time may now be reduced by making testing available in these additional settings."
The XW-100 Automated Hematology Analyzer 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 of patients with serious conditions such as severe anemia (low red blood cell or hemoglobin count) and agranulocytosis (low white blood cell count), who require additional testing. 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 works by using a blood sample to classify and quantify 12 different blood characteristics (hematology parameters), which provides patients with a blood component profile as part of their overall health assessment.
The XW-100 Automated Hematology Analyzer was granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The CLIA waiver for this device allows it to be used by a variety of non-traditional laboratory sites, including physicians' offices, clinics or other types of health care facilities with a CLIA Certificate of Waiver (CLIA-waived settings). CLIA, a program run by the Centers for Medicare & Medicaid Services (CMS), oversees all U.S. laboratory testing (except for laboratory testing for research purposes) performed on human specimens. The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. CLIA regulations describe three levels of test complexity: waived tests, moderate complexity tests and high complexity tests. Although CMS oversees the CLIA program, the FDA is responsible for categorizing the complexity of tests. According to CMS, more than 180,000 laboratories are certified to perform waived testing. These CLIA-waived laboratories are not the same as clinical laboratories accredited to perform more complex testing.
The XW-100 Automated Hematology Analyzer was reviewed through the Dual Submission pathway, a streamlined regulatory pathway for both marketing clearance (510(k)) and CLIA Waiver by Application. A 510(k) notification is 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. 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 the use of this device in CLIA-waived settings with non-medical personnel, the analyzer provides simple instructions for operator actions when results are flagged or outside of a specified range. 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. The XW-100 was granted clearance and a CLIA waiver after determining 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 ranging from 2 to 92 years old. The study compared the XW-100 test results collected by non-medical personnel in CLIA-waived settings to a hematology analyzer in an accredited clinical laboratory. Results found that by following the manufacturer's instructions for use, accurate testing can be effectively conducted by untrained personnel.
The FDA granted premarket clearance and a CLIA waiver for the XW-100 Automated Hematology Analyzer to Sysmex America, Inc.