The Food and Drug Administration (FDA) has cleared the XW-100 Automated Hematology Analyzer, a complete blood cell count (CBC) test intended for use in patients ≥2 years old who require a whole blood cell count and white blood cell differential.
The device was granted a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) which allows it to be used by a variety of settings, including physicians’ offices, clinics or other types of healthcare facilities with a CLIA Certificate of Waiver.
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. In addition, the number of hematology parameters has been reduced to 12 to ensure accurate testing in this setting.
The device was cleared based on data from a study conducted on 582 patients samples (age range: 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 showed accurate testing can be effectively conducted by non-medical personnel by following the instructions for use.
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The XW-100 Automated Hematology Analyzer should not be used to diagnose or monitor oncology patients, children <2 years old, or in chronically ill or critically ill patients.
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