Dade Behring Receives 510(k) Clearance for Its Dimension Vista(TM) 1500 Integrated System
Dade Behring (NASDAQ:DADE), the world’s largest company solely dedicated to clinical diagnostics, today announced that its Dimension Vista(TM) 1500 integrated system, which will be the company’s first integrated chemistry/ immunochemistry system targeted at high-volume clinical laboratory customers, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This is the first of a series of submissions and approvals prior to the anticipated commercialization of the Dimension Vista(TM) system in the second half of 2006.
“The Dimension Vista(TM) system is the foundation for a whole new generation of Dade Behring analyzers and builds on the success of Dade Behring’s Dimension(R) RxL and Xpand(TM) systems. This clearance is an important milestone in preparation for the product launch, and we feel confident that once commercialized, this system will be an innovative and effective solution to our customers’ real day-to-day issues in the lab,” said Jim Reid-Anderson, Chairman, President and CEO, Dade Behring. “The new system will significantly advance the integrated testing capability we offer our customers, continuing to enhance Dade Behring’s leadership in the chemistry/immunochemistry market segment, which accounts for the majority of the test volume in clinical laboratories.”
In addition to the clearance of the Dimension Vista(TM) system, seven tests were cleared including Urea Nitrogen (BUN), Immunoglobulin G (IGG), Phenobarbital (PHNO), Mass Creatine Kinase MB Isoenzyme (MMB), and the V-LYTE(TM) Integrated Multisensor Sodium (Na), Potassium (K), and Chloride (Cl) panel. Each test represents a different detection capability, reinforcing the breadth of testing the Dimension Vista(TM) system will be capable of performing.
The Dimension Vista(TM) 1500 integrated system will combine photometry, turbidemetry, nephelometry, IMT (integrated multisensor technology) and LOCI(TM) technologies. The new design will integrate analysis of electrolytes, general and special chemistries, drugs-of-abuse, therapeutic drugs, immunosuppressive drugs, plasma proteins, cardiac marker tests and high-sensitivity immunoassays into one analyzer.
About Dade Behring
With 2004 revenues of nearly $1.6 billion, Dade Behring is the world’s largest company dedicated solely to clinical diagnostics. It offers a wide range of products, systems and services designed to meet the day-to-day needs of labs, delivering innovative solutions to customers and enhancing the quality of life for patients. Additional company information is available on the internet at www.dadebehring.com .
