The Food and Drug Administration (FDA) has granted premarket clearance and a CLIA waiver to Sysmex America for its complete blood cell count (CBC) test, the XW-100 Automated Hematology analyzer. This is the first CBC test to receive a CLIA waiver, enabling non-traditional laboratory sites, such as physicians’ offices, and nonmedical staff to perform it. 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. FDA reviewed the device through the Dual Submission pathway, which is a streamlined regulatory pathway for both 510(k) clearance and CLIA Waiver by Application. To support the use of this device in CLIA-waived settings with untrained operators, the analyzer provides simple instructions for what to do when results are flagged or outside of a specified range. The number of hematology parameters has also been reduced to 12 to eliminate results that are most susceptible to inaccuracy or require additional testing.