FDA clears Roche Cobas c 703, Cobas ISE Neo

May 2026—The Food and Drug Administration granted 510(k) clearance to Roche’s Cobas c 703 and Cobas ISE Neo analytical units. As part of the Cobas Pro integrated solutions, the units are designed to help address laboratory challenges, including staff shortages, limited space, and increasing test volumes. The Cobas c 703 delivers up to 2,000 tests per hour and offers 70 reagent positions. The Cobas ISE Neo delivers up to 1,800 tests per hour and reduces hands-on time through automated maintenance. Both systems offer monthly operator maintenance.

With Cobas Pro integrated solutions, the required sample volume per test has been reduced by 43 percent on average compared with previous-generation systems, and the plastic generated per test result has been reduced by up to 78 percent due to smaller reagent pack sizes and higher number of tests per pack.

Roche Diagnostics, 800-428-5074