FDA clears Roche High-Volume Immunoassay Lab Testing Solution to Support Critical Medical Treatment

Roche announced its new, high-volume testing immunoassay solution for the cobas 8000 modular analyzer series, the cobas e 801 module, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Designed for maximum consolidation at a high throughput, the module reduces generated waste, for more environmentally sustainable testing.

"The cobas e 801 module truly is a transformative solution," Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation said. "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."

The cobas e 801 module almost doubles the currently available immunoassay testing capacity on the same footprint, delivering up to 300 tests per hour and providing 48 reagent channels.