FDA approves XW-100 Automated Hematology Analyzer blood cell test - Sysmex America, Inc.

The FDA has cleared a complete blood cell count (CBC) test that, based on its categorization, can be run in more health care settings, including physicians’ offices, clinics or other types of health care facilities, by a wider range of personnel (e.g. support staff). This broadened test access will allow for faster availability of results.

The XW-100 Automated Hematology Analyzer from Sysmex America, Inc., 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 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.