FDA Clears VITROS® 5600 Integrated System for Laboratory Diagnostics

Integrated System Heralds New Potential for Clinical Laboratories

Raritan, NJ . – Ortho Clinical Diagnostics today announced 510(k) clearance from the United States Food and Drug Administration (FDA) for its VITROS® 5600 Integrated System. This next generation system is uniquely designed to integrate clinical chemistry and immunoassay testing to increase laboratory productivity and will be able to perform more than 100 different chemistry, immunoassay and infectious disease assays on a single, high-quality system. In addition to its current broad menu including user-defined applications, the VITROS® 5600 Integrated System will have the capability to run future tests for earlier detection of diseases. Commercial availability is expected in the fourth quarter of this year.

“There are fewer steps for each test specimen going through the VITROS® 5600 Integrated System,” said Dr. John Chapman, Director of Core/Clinical Chemistry Laboratories and Point-of-Care Testing at University of North Carolina Hospitals. “It builds on the cost savings, quality and efficiency of its predecessors and adds enhanced immunoassay capability, one of the fastest growing diagnostic areas. The timing is perfect for the introduction of this innovation to meet current and future needs of high volume labs.” Dr. Chapman is a principal investigator for the VITROS® 5600 Integrated System and a paid consultant retained by Ortho Clinical Diagnostics.

“The VITROS® 5600 Integrated System will consolidate and simplify testing and proves you do not have to compromise quality to gain efficiency,” said Ortho Clinical Diagnostics Worldwide Commercial President Mark Straley. “By incorporating the flexibility to accommodate novel clinical diagnostic tests, this world-class system has the potential to help doctors diagnose disease earlier and make better informed treatment decisions for patients.”

Ortho Clinical Diagnostics is pursuing a worldwide registration program for the VITROS® 5600 Integrated System. The System has been registered for distribution by the Pharmaceutical and Medical Device Agency (PMDA) in Japan.

About the VITROS® 5600 Integrated System

Workflow data and input from 60 clinical laboratories worldwide drove the next-generation design of the VITROS® 5600 Integrated System. The integrated system incorporates market-proven VITROS® technologies into one of the easiest to use and most compact systems on the market. The platform is designed to meet the centralized testing needs of customers managing skilled labor shortages, budget restrictions and increasing test volumes. One of its patent-pending innovations is the “Sample-Centered” processing approach, where each individual sample is accessed independently and in parallel for chemistry and immunoassay testing. Unlike other integrated systems, this “one tube in, one tube out” approach can optimize turnaround time and productivity by intelligently accounting for variable sample and test mixes, eliminating the need to split the sample on the analyzer or move sample trays between modules.

The VITROS® 5600 Integrated System is smaller than many other systems and does not have any water or drainage requirements, making the most of limited lab space while allowing flexibility in instrument location. The VITROS® 5600 Integrated System will maintain the same high quality benchmark of all VITROS® products by using the same reagents across a large worldwide base of chemistry and immunodiagnostic systems.

“Beyond continually improving our existing diagnostic products,” continued Straley, “Ortho Clinical Diagnostics is collaborating with industry leaders and investing significant resources to help develop specific disease-state biomarkers in reproductive health, oncology, cardiology and metabolic diseases. Our ultimate goal is to foster early detection and intervention to significantly reduce disease burden and improve patient quality of life.”

About Ortho Clinical Diagnostics

Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, delivers the high quality in-vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to ensure every patient receives blood that’s safe, the right type, and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com.