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Home » May 2017, Top news

Roche’s Cobas e 801 510(k) cleared

May 11, 2017Roche announced that its new, dedicated high-volume testing immunoassay solution for the Cobas 8000 modular analyzer series, the Cobas e 801 module, has received 510(k) clearance from the Food and Drug Administration.

The Cobas e 801 almost doubles the currently available immunoassay testing capacity on the same footprint, delivering up to 300 tests per hour and providing 48 reagent channels. Up to four modules can be configured in a series, delivering up to 1,200 tests per hour across up to 192 reagent positions. The system may also be integrated with the Cobas 8100 automated workflow series and Roche middleware featuring Lab Intelligence.

It is designed to use at least 25 percent less patient sample than its predecessor and allows for continuous, on-the-fly loading of reagents and consumables, Roche says.

“The Cobas e 801 module truly is a transformative solution,” Alan Wright, MD, chief medical officer of Roche Diagnostics, said in a statement. “Patients and the physicians who serve them need medically relevant answers, faster and with ever greater precision. This clearance delivers the instrumentation cornerstone of the next-generation lab—high throughput, agility, and intelligence.”

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