Roche has secured the US Food and Drug Administration (FDA) 510(k) approval for cobas pure integrated solutions, its new-generation work area platform intended for low- to mid-volume labs.
The new platform is the latest addition to the company’s cobas family of Serum Work Area solutions.
The compact and modular solution is designed to combine clinical chemistry, immunoassay and Ion-Selective Electrode (ISE) diagnostic testing, on a single platform.
In addition, it comes with automated maintenance, automated calibration and turnkey reagents to help simplify the lab operations.
The new solution automates the manual tasks and reduces the technicians’ maintenance time to just five minutes per day to improve the productivity of lab personnel, said the company.
Roche Diagnostics North America president and CEO Matt Sause said: “The cobas pure integrated solutions mark a significant milestone in evolving standardisation in lab diagnostics. Lab professionals are charged with providing life-impacting results quickly, accurately and efficiently.
“This system delivers a broad menu of medical assays while simplifying operations and reducing hands-on time for laboratorians so that they can focus on the tasks that matter most.”
With an about 21ft2 footprint, which is up to 30% smaller than the previous generation, the cobas pure system is said to optimise space and resources for low- to mid-volume labs.
Roche claimed that the system uses low-volume patient samples to deliver the test results within short and predictable turnaround times.
The device can perform up to 870 tests per hour, and access to the Swiss drugmaker’s complete clinical chemistry and immunochemistry assay menu.
The menu will include more than 186 diagnostic tests covering disease areas such as infectious diseases, oncology and cardiology, within the first year after launch.
It will enable low- to mid-volume labs to make better use of their space and expand their offering of high medical value tests for the benefit of patients, said Roche.
