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Ortho Clinical Diagnostics Procalcitonin Assay Receives FDA Clearance

NEW YORK – Ortho Clinical Diagnostics announced Monday its Vitros BRAHMS procalcitonin assay to identify bacterial infections received 510(k) clearance from the US Food and Drug Administration.

The assay will be available on the Vitros 3600 Immunodiagnostic System, Vitros 5600 and Vitros XT 7600 Integrated Systems, and Vitros ECi/ECiQ Systems. It can help with early detection of severe bacterial infections, including sepsis, acute bronchitis, and community-acquired pneumonia, the company said.

The test has a calibration interval of 56 days and a sample size of 30L, and the company's Vitros technology has a 96.5 percent first pass yield, Ortho said. The instruments use MicroSensor technology to detect results with potential hemolysis, icterus, and turbidity interferences.

The Vitros XT 7600 Integrated System received clearance from the FDA in 2018.