FDA has recently granted premarket notification (510(k)) clearance for the Ortho Vision analyzer, a fully automated and interactive analyzer for transfusion medicine laboratories by Ortho-Clinical Diagnostics (OCD), Raritan, NJ.
The newly cleared analyzer makes use of OCD’s ID–microtyping system (ID-MTS) gel column agglutination technology. A version of the Ortho Vision analyzer is already commercially available in Australia, Canada, Europe, Japan, and Latin America. With FDA’s recent clearance, OCD has announced that the analyzer is now also commercially available in the United States and Puerto Rico.
Although transfusion medicine has evolved to enhance safety and establish critical efficiencies, says OCD, today’s automation solutions lack the ability to anticipate and respond to individual user needs and ever-changing conditions within the laboratory. The Ortho Vision analyzer pairs secure monitoring technologies with dynamic workflow management, enabling labs to address unpredictable demands when needed and have confidence in the results.
Robert Yates, Ortho-Clinical Diagnostics.
“With the launch of the Ortho Vision analyzer, our goal is to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods,” says Robert Yates, chief operating officer at OCD. “Lab professionals are required to provide results quickly in spite of the continuous strain on resources. The Ortho Vision analyzer fits into our broader portfolio of integrated solutions that empower our customers to respond to these growing pressures and help contribute to delivering the best patient care.”
Ortho-Clinical Diagnostics serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe. The company also brings information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care.
Heidi Casaletto, Ortho-Clinical Diagnostics.
Designed with secure monitoring technologies for safety checks and balances, the Ortho Vision analyzer gives transfusion medicine professionals the ability to track critical steps in the immunohematology testing process. Using OCD’s proprietary Intellicheck technology, the Ortho Vision analyzer verifies and documents diagnostic checks throughout the testing process, while its e-Connectivity technology provides 24/7 remote data tracking that monitors instrument performance and maximizes uptime. Laboratory personnel can also log on anytime, anywhere, to collaborate on interpreting results in real time for an extra level of confidence.
“The Ortho Vision analyzer eliminates the tradeoffs blood bankers are typically forced to make,” says Heidi Casaletto, head of transfusion medicine at Ortho-Clinical Diagnostics. “Now lab personnel will be able to focus on prioritizing tests as they are requested—including stats—which reestablishes a natural workflow. This helps decrease time to results and drives productivity.”
For more information, visit Ortho-Clinical Diagnostics.
