Roche Receives FDA Clearance for U.S. Launch of cobas 8000 Modular Analyzer Series for High-Volume Laboratory Testing
INDIANAPOLIS, Sept. 13 /PRNewswire-FirstCall/ -- Roche Diagnostics (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the cobas® 8000 modular analyzer series, a Serum Work Area solution designed for diagnostic laboratories with a workload of 3-15 million clinical chemistry / immunochemistry tests per year.
The cobas 8000 series is the newest member of the Roche cobas modular platform family, which combines clinical chemistry and immunochemistry testing. With a peak throughput of up to 9,800 tests per hour and up to 280 reagents onboard, it offers a variety of features to help high-volume labs deliver reliable test results with greater efficiency and throughput. The system also provides extensive modular flexibility so labs can configure tailored solutions to meet their individual needs.
With the introduction of the cobas 8000 modular analyzer series, Roche now offers a comprehensive portfolio of standardized integrated systems to meet the needs of all types and sizes of clinical laboratories: the stand-alone cobas 4000 analyzer series for low-volume labs; the cobas 6000 analyzer series for mid-volume labs; and the cobas 8000 modular analyzer series for high-volume labs.
"The cobas 8000 modular analyzer series delivers a new dimension in productivity, process innovation and consolidation for high-volume laboratories," said Jack Phillips, president and CEO of Roche Diagnostics Corporation. "There are many innovative design elements that help reduce sample turnaround time, and the modular design gives labs the freedom to