Patient safety and their needs are at the heart of the XW-100


For more than 50 years, patient safety has been the heart of what we do at Sysmex. Our commitment to patients is why our diagnostic solutions are known throughout the world for their safety, accuracy and reliability.

Today, patients want faster results, earlier starts of treatment plans and fewer trips to the doctor’s office.

  • The XW-100 is the culmination of an extensive, deliberate, thoroughly-researched and studied effort, which included laboratory and non-laboratory staff, to ensure the safety and efficacy of a high-quality hematology analyzer able to deliver accurate and reliable results in a CLIA-waived, primary care setting. Over the course of the development process, we met with the FDA multiple times in a rigorous process to ensure the device fully met their requirements. 
    • The XW-100 provides complete blood count (CBC) screening, one of the most frequently requested tests, and uses a blood sample to classify and quantify 12 different blood characteristics.
  • The XW-100 also contains several innovative, first-of-its-kind, built-in safety systems in a hematology device, many of which have never before been offered. To start, every instrument is subject to a number of stringent safety tests before it even arrives in a doctor’s office. For example, it is factory-calibrated in a controlled environment. Then, the XW-100’s innovative software contains safety lockouts, fail-safe and alert mechanisms to ensure the following:
    • Use of reagents and quality control material within their shelf life (prior to the expiration date)
    • Use of quality control material within open container stability limits
    • Quality control every eight hours of use
    • Quality control with use of a new reagent
    • Lock-out of patient testing if quality control results are out of range
    • Suppression of test results in the event the sample is compromised, preventing the reporting of erroneous results
    • No testing of patients less than two years of age, based on date of birth entry
    • Patient results are not displayed on screen, but are printed
  • Patients want their results faster. In a 2016 study, 37% of patients said that not being able to get laboratory results during the same visit was the reason a health provider failed to meet their expectations. And they want to avoid travel to more than one location and follow-up visits to discuss test results.
  • The XW-100 allows a physician to determine what may be affecting a patient, and start a treatment plan – and likely on the path to better health – faster.


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The Sysmex XW-100 was designed and built with input and recommendations for Clinical Laboratory Improvement Amendments (CLIA)-waived devices from expert hematology scientists and physicians.

  • The FDA has cleared more than 1,400 CLIA-waived testing systems, including testing for medical conditions such as HIV/AIDS, the Hepatitis C Virus and Influenza.
  • The instrument was cleared by the U.S. Food and Drug Administration (FDA) after a rigorous review process.
  • According to the FDA, “The FDA reviewed data from a study conducted on 582 samples collected from patients ranging from 2 to 92 years old.”
  • The XW-100 supports CLIA-waived tests, one of three diagnostic test complexity types that doctors order. It will not replace tests of moderate complexity nor high complexity, which will continue to be conducted in larger, more complex laboratories, and of course offer many more parameters.
  • As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. They include certain tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Sites performing only waived testing must have a CLIA certificate and follow the manufacturer’s instructions.
  • The Sysmex XW-100 is a complementary and natural extension of our existing line of core laboratory solutions, developed to meet the needs of labs of every size. Approximately 180,000 laboratories are certified to perform CLIA-waived testing.


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The XW-100 is the culmination of an extensive, deliberate, thoroughly-researched and studied effort, to ensure the safety and efficacy of a high-quality hematology analyzer that can deliver accurate and reliable results in a CLIA-waived primary care setting. It is built on the company’s reliable, trusted and proven technology honed by Sysmex scientists over the past half-century.

  • Sysmex has made significant investments in comprehensive testing and market acceptance studies.
  • The company has also built a robust infrastructure and related systems to ensure the XW-100 safely, accurately and reliably serves health care professionals and the patients who depend on them. 
  • Sysmex is the global hematology diagnostic leader, and remains every bit as committed to its customers as it has for decades.
  • Sysmex has been a leader in clinical laboratory diagnostics for more than 50 years, and will continue to invest heavily in the clinical science of hematology.

 Learn more about the journey in developing this novel solution in a new Dark Report article.

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Available Now in the U.S. through McKesson,
the Exclusive Distributor of XW-100

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