Ortho-Clinical Diagnostics, a Johnson & Johnson company, has received clearance from the US Food and Drug Administration (FDA) to begin marketing the VITROS 5, 1 FS Chemistry System, the first in the VITROS Fusion Series. 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, says Laurel LaBauve, general manager and vice president of the Worldwide Clinical Laboratory Franchise for Ortho-Clinical Diagnostics.
The VITROS 5, 1 FS Chemistry System will feature Ortho-Clinical Diagnostics proven MicroSlide technology for the highest-reportable-result efficiency and Intellicheck 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 MicroTip reagents, which will provide an extended menu of special chemistry and immunoassay methods. MicroTip technology is unusual 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. The test measures HDL cholesterol in serum and plasma with no pretreatment.
By integrating up to 80 routine and special chemistry assays onboard through the use of Intelligent Parallel Processing, 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 of marketing, Worldwide Clinical Laboratory Franchise, Ortho-Clinical Diagnostics.