> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Roche Sepsis Assay Cleared by FDA
- URL: https://www.fdaweb.com/roche-sepsis-assay-cleared-by-fda/
- Published: 2016-06-23T12:00:00.000Z
- Updated: 2026-09-14T21:11:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136036

FDA has cleared a Roche 510(k) for its Elecsys Brahms PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. “PCT is a sepsis-specific biomarker associated with bacterial infection and PCT levels in blood can aid clinicians in assessing the risk of sepsis as well as managing the disease when present,” the company says. The test can aid in assessing the risk of critically ill patients progressing from severe sepsis to septic shock; and help determine the 28-day mortality risk in sepsis patients, it says.

Clearance was based on data from a U.S. multicenter study called 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,” the company says.

Roches says the assay is designed to provide full automation, meaning no reagent preparation or hands-on testing is required. It offers same-day testing capability with a short incubation time (18 minutes). It also has a broad measuring range (0.02 – 100 ng/mL, extending to 400 ng/mL with a recommended 1:4 dilution), it says.