Roche’s new analytical units receive FDA 510(k) clearance

These systems automate tasks traditionally performed manually, accelerating turnaround times and enhancing overall laboratory performance.
April 1, 2026

Roche announced they have received U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas c 703 and cobas ISE neo, its newest analytical units.

Information from Roche about the analytical units:

  • The new cobas c 703 was designed to double the clinical chemistry throughput on cobas pro integrated solutions, delivering up to 2,000 tests per hour and 70 reagent positions. Its expanded reagent capacity enables more high-value tests to run continuously, reducing reagent reloads and improving workflow efficiency. Monthly operator maintenance further enhances uptime and productivity.
  • The cobas ISE neo analytical unit, with up to 1,800 tests per hour, delivers more efficient ISE testing, reducing hands-on time through automated maintenance. The cobas ISE neo system delivers more tests per reagent bottle, minimizing plastic waste and reducing logistical efforts compared to previous-generation systems. Monthly maintenance supports consistent uptime, helping laboratories manage higher volumes with fewer manual steps.

Together, these units automate tasks traditionally performed manually, supporting laboratories facing staffing shortages while increasing test capacity and accelerating turnaround times.

Visit Roche for more information

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