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Roche Gets FDA 510(k) Clearance for New Cobas Instrument

NEW YORK – Roche announced on Monday that its Cobas Pure Integrated Solutions instrument has received 510(k) clearance from the US Food and Drug Administration.

The automated instrument integrates clinical chemistry, immunoassay, and ion-sensitive electrode testing on one platform and is intended for use by low- to mid-volume laboratories, the firm said in a statement. It also integrates with Roche's Cobas Pro instrument for mid- to high-volume labs.

The platform is up to 30 percent smaller than Roche's previous generation systems and can perform up to 870 tests per hour with access to Roche's full clinical chemistry and immunochemistry test menu. Within a year, the menu will include more than 186 assays across infectious diseases, oncology, and cardiology, Roche said.

"This system delivers a broad menu of medical assays while simplifying operations and reducing hands-on time for laboratorians so that they can focus on the tasks that matter most," Roche Diagnostics North America President and CEO Matt Sause said in a statement.

The platform received CE marking in March 2021.