FDA clears Ortho Clinical Diagnostics’ VITROS XT MicroSlides

Ortho Clinical Diagnostics’ VITROS^® XT MicroSlides, featuring new, multi-test technology that allows labs to run two tests simultaneously on one MicroSlide, have been cleared for market by the U.S. Food and Drug Administration. The product pairs tests that physicians typically order together while maintaining the high-quality results that physicians expect from Ortho’s MicroSlide technology. Available test pairs include: triglycerides and cholesterol; urea and creatinine; and glucose and calcium.

By pairing commonly ordered tests so they can be run simultaneously, Ortho’s VITROS^® XT MicroSlides, which are available for use on Ortho’s VITROS^® XT 7600 Integrated System, improve performance and productivity in the clinical lab. This enables a higher test throughput without requiring additional or larger analyzers. This is a significant benefit in a hospital environment, where space is often at a premium. In addition, the miniaturized testing areas on each MicroSlide require less patient blood sample for each of the paired tests, an important advantage for vulnerable patients or those with venous access issues. Ortho’s VITROS^® XT MicroSlides are powered by DIGITAL CHEMISTRY^™ technology, available in the VITROS^® XT 7600 Integrated System, which uses advanced optics to glean significantly more information from each test than was possible before.

Labs today are challenged to run increasing volumes of tests in shorter timeframes, with less physical space available for larger analyzers. Because they enable the simultaneous running of two tests that are typically ordered together, our VITROS XT MicroSlides address these numerous challenges with one elegant solution.”

Michael Iskra, head of Ortho’s North America operations

Ortho’s VITROS^® XT MicroSlides, which include VITROS^® XT UREA-CREA, TRIG-CHOL, and GLU-Ca Slides, have been cleared by the U.S. Food and Drug Administration. In addition, they have received CE Mark, signifying conformance to applicable European Union regulatory requirements. These products are available on the VITROS^® XT 7600 Integrated System in numerous countries, including the U.S., Canada, Chile, France, Germany, Hong Kong, Iceland, Italy, Spain, Switzerland, the U.K., Australia, Liechtenstein, Norway and New Zealand.