Ortho-Clinical Diagnostics Announces 510(k) Clearance for the VITROS 5,1 FS Chemistry System
RARITAN, NJ (August 15, 2003) — Ortho-Clinical Diagnostics, a Johnson & Johnson company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing the VITROS 5,1 FS Chemistry System, the first in the VITROS Fusion Series of Systems.
“The introduction of the VITROS 5,1 FS Chemistry System continues to extend the market leadership of VITROS Systems to the clinical laboratory market by providing state-of-the-art systems that meet the needs of our customers,” said Laurel LaBauve, General Manager and Vice President of the Worldwide Clinical Laboratory Franchise for Ortho-Clinical Diagnostics. “The introduction of the VITROS 5,1 FS will allow us to double our current test menu while continuing to provide the simplified system operation that our customers have come to expect.”
The VITROS 5,1 FS Chemistry System will feature Ortho-Clinical Diagnostics’ proven MicroSlideÔ Technology for the highest reportable result efficiency and IntellicheckÔ Technology for system monitoring and advanced clot and bubble detection. In addition, the VITROS 5,1 FS Chemistry System is the first system to support the new VITROS MicroTipÔ reagents, which will provide an extended menu of special chemistry and immunoassay methods. MicroTip Technology is unique because it eliminates the maintenance and cost associated with water, plumbing, drains, fixed probes and mixing assemblies. The first test to utilize MicroTip Technology, the VITROS Chemistry Products dHDL Reagent Pack, has also received 510(k) clearance from the FDA. This test measures HDL cholesterol in serum and plasma with no pretreatment.
“By integrating up to 80 routine and special chemistry assays on board through the use of Intelligent Parallel ProcessingÔ, we believe that the VITROS 5,1 FS Chemistry System will raise industry standards for simplified operation, integrity of results, and operational efficiency,” says Stephanie Wells, Vice President Marketing, Worldwide Clinical Laboratory Franchise, Ortho-Clinical Diagnostics.
The VITROS 5,1 FS Chemistry System is the first in the VITROS Fusion Series of Systems, which will consist of multiple chemistry, immunodiagnostics, and integrated systems for low-, medium- and high-volume testing applications. The VITROS Fusion Series is unique because it is designed to simply and efficiently integrate chemistry, special chemistry, immunoassay, and infectious disease assays, including a growing menu of hepatitis tests.
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the Company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help to ensure the safety of the world’s blood supply. In addition, through its patented MicroSlide™ and enhanced chemiluminescence technologies, the Company transformed the way that clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions that promote effective diagnoses and enhanced patient care.
