FDA gives 510(k) approval for Elecsys BRAHMS PCT (procalcitonin) assay in sepsis detection- Roche
Roche has received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. With this clearance, Roche is the first IVD company in the U.S to provide a fully integrated solution for sepsis risk assessment and management.
The clearance of Roche's PCT solution is a result of the U.S. multicenter Procalcitonin Monitoring Sepsis Study (MOSES). The novel trial design of Thermo Fisher Scientific's MOSES study leveraged the same patient samples to enable a "universal analysis" approach to demonstrate substantial equivalence to the FDA resulting in the clearance of the Elecsys BRAHMS PCT assay.
Comment: The Elecsys BRAHMS PCT assay is designed to provide full automation, which means no reagent preparation or hands-on testing is required. This assay offers same-day testing capability with an incubation time of only 18 minutes.
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