- Source : PR Newswire
- Date : 2020-07-23
- Event type : Approved
- Companies : Beckman Coulter, Inc., Danaher Corp.
Beckman Coulter's Automated Blood Banking Analyzer Receives 510(k) FDA Clearance
BREA, Calif., July 23, 2020 /PRNewswire/ -- Beckman Coulter today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its PK7400 Automated Microplate System and the system's reagents have completed FDA approval. Designed for use in blood donor and plasma centers, as well as large reference laboratories, the PK7400 Automated Microplate System offers the industry's highest throughput for a single analyzer in its class and is now available in countries across Europe, Canada and the United States.
According to the AABB (formerly the American Association of Blood Banks), an estimated 33,000 units of blood are needed each day to meet patient need. However, the organization also stated, more than 4,000 blood donation events have been cancelled due to the COVID-19 pandemic.
"Blood donation is critically important under normal circumstances, as one donation can save up to three lives, but even more so now," said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter. "During this challenging time, those that are feeling well and healthy should continue to make and keep donation appointments to help ensure life-saving blood is available for patients that need it most."
"Along with the need for physical donors, blood donation and plasma centers require tools that enable them to reliably test and process the samples that are coming in, so they can quickly make them available for patients," said Kathleen Orland, vice president and general manager of Beckman Coulter's Chemistry and Immunoassay business. "Our PK7400 is designed to optimize workflow, minimize hands-on time and increase productivity, allowing users to focus their time on protecting the health and safety of donors, patients and blood center staff."
The PK7400 Automated Microplate System:
- Offers the industry's highest throughput for a single analyzer in its class, processing up to 300 samples per hour with a maximum of 12 tests per sample
- Includes proprietary liquid and ready-to-use reagents
- Provides the end user the ability to test multiple assays in a single batch without decreasing the throughput
- The assay menu includes ABO blood grouping, Rh typing, weak D testing, Rh-Kell phenotyping, as well as syphilis and CMV qualitative screening†
"The PK7400 is a user-friendly analyzer with the capacity to test a large throughput with rapid, accurate results," said Christie Garza, laboratory specialist at Gulf Coast Regional Blood Center. "The software is easy to navigate, and results can be interpreted quickly and easily."
For details on where to donate blood locally, see AABB's blood donor center locator. For more information on the PK7400, visit www.beckmancoulter.com/pk7400.
About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory's role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation (NYSE: DHR) since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
† For Investigational Use Only. The performance characteristics of this product have not been established. Pending clearance by the United States Food and Drug Administration; not yet available for in vitro diagnostic use in the US.
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SOURCE Beckman Coulter Diagnostics