Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves CBC Test for Office Use
FDA news release; 2017 Nov 6
The FDA has cleared a complete blood cell count (CBC) test and approved categorization that allows it to be run in more health care settings, including physicians’ offices, clinics, or other types of health care facilities, and by a wider range of personnel.
Indications: The XW-100 Automated Hematology Analyzer is intended for use in patients ≥2 years of age who require a whole blood cell count and white blood cell differential to provide early alerts of patients with serious conditions such as severe anemia and agranulocytosis. It should not be used to diagnose or monitor patients with primary/secondary hematologic diseases.
Administration: The device works by using a blood sample to classify and quantify 12 different blood characteristics, providing a blood component profile.
Efficacy and safety: A study involving 582 individuals demonstrated the test’s ease of use and low risk of false results when used by untrained operators.
FDA clears common blood cell count test that offers faster results for patients and providers. [news release]. Silver Spring, MD: FDA. November 6, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583997.htm?utm_campaign=11062017_FDA%20clears%20blood%20cell%20count%20test&utm_medium=email&utm_source=Eloqua. Accessed November 6, 2017.