Roche Diagnostics has received 510(k) clearance for the Cobas 8000 modular analyser series, a serum work area solution designed to enhance efficiency in high-volume diagnostic laboratories.
The 510(k) clearance was granted by the US Food and Drug Administration (FDA).
The Cobas 8000 series is designed for diagnostic laboratories with a workload of three million to 15 million clinical chemistry/immunochemistry tests per year.
With a peak throughout of up to 9,800 tests per hour and up to 280 reagents onboard, Roche said the series offers a variety of features to help high-volume laboratories deliver reliable test results with greater efficiency and throughput.
The system also provides extensive modular flexibility so laboratories can configure tailored solutions to meet their individual needs.
With the introduction of the Cobas 8000 modular analyser series, Roche said it can now offer a comprehensive portfolio of standardised integrated systems to meet the needs of all types and sizes of clinical laboratories: the standalone Cobas 4000 analyser series for low-volume laboratories; the Cobas 6000 analyser series for mid-volume laboratories; and the Cobas 8000 modular analyser series for high-volume laboratories.
The Cobas 8000 modular analyser series features intelligent sample routing with fast transportation and return lines, independent processing lines within each module, and a modular sample buffer in each module for true random-access sampling.
The series also uses the same operator interface and the standardised reagent cassette concept used on other Cobas analyser platforms.
Tests run on the platform give physicians important clinical information in a range of medical areas, such as cardiac and infectious diseases, bone disorders and cancer.
The first configuration of the system includes two clinical chemistry analytical modules: the high-volume Cobas c701 module (up to 2,000 tests/hour) and the mid-volume Cobas c502 module (up to 600 tests/hour).
The system automatically manages samples to provide optimal throughput by allocating the most frequently requested assays to the high-volume module and less frequently requested assays to the mid-volume module.
Roche anticipates that the system's immunochemistry module, the Cobas e602 analyser, will be available in October 2010.
The Cobas e602 module is currently in development/for research use only - the product is not available in the US.
With the addition of this module, laboratories will be able to combine chemistry and immunochemistry modules to create 24 unique system configurations to match their specific testing needs.
