Roche’s Cobas Pure Integrated Solutions Gains FDA Clearance

September 21, 2022

Roche has received 510(k) clearance from the FDA for the latest addition to its cobas laboratory diagnostic equipment, the “cobas pure integrated solutions” system.

The modular system, which combines clinical chemistry, immunoassay and ion-selective electrode diagnostic testing in a single platform, can perform up to 870 tests per hour.

With a footprint of about 21 square feet, the compact test equipment could help low- and mid-volume laboratories optimize space and resources, the company said.

The automated system reduces the required sample volume per test on average by 43 percent compared to previous systems and reduces the plastic generated per test result by up to 78 percent due to smaller reagent pack sizes with higher number of tests per pack, Roche said.

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