New Chemistry And Immunoassay Analyzer Cleared By FDA
FDA Clears the New cobas 6000 analyzer series' the Next Generation Integrated Analyzer for Clinical Chemistry and Immunoassay Testing
Roche Diagnostics expands their Single Solution to the Mid-Volume Laboratory
Roche Diagnostics announced that it has received U.S. Food and Drug Administration (FDA) clearance on its next generation of analyzers, the cobas 6000 analyzer series. This analyzer provides laboratories with an integrated clinical chemistry (cobas c 501 analyzer) and immunoassay (cobas e 601 analyzer) testing platform as well as a small footprint and an easy-to-use interface.
"Roche Diagnostics now offers a single solution for mid-volume laboratories' linking pre-analytics, analytics, and connectivity options. This new analyzer was developed with these facilities in mind, combining chemistry and immunoassay tests with reliability and ease of use," said Andrew Thomson, Senior Vice President, Centralized Diagnostics, Roche Diagnostics. "In addition, the cobas 6000 analyzer series offers laboratories seven different configuration options, so it is able to adapt to the laboratories' changing needs."
The cobas 6000 analyzer series delivers approximately 95 percent of a lab's typical testing mix of more than 130 assays, including:Substrates, Enzymes, Electrolytes, Therapy drug monitoring, Drugs of abuse testing, Proteins, Cardiac markers, Thyroid, Tumor markers, Bone markers, Fertility, Anemia, Diabetes, and Proteins.
This integrated, broad menu streamlines workflow processes and efficiency, running a throughput of up to 1,170 tests, per hour including a STAT interruption mode, which prioritizes STAT racks to be sampled within 60 seconds. The cobas 6000 analyzer series can accommodate front-end automation with the MODULAR PRE-ANALYTICS system, eliminating off-line sample preparation and reducing the potential for human error. This yields higher quality, improved productivity, simplified workflow, and cost savings. Also available is Middleware Solutions, connecting existing laboratory information systems (LIS) to the cobas 6000 analyzer series. Rules-based decision making which includes auto verification, archiving, and real-time reflexive testing fills many of the information system gaps common in many laboratories today.
The analyzer also includes several unique features. The new sample probe can pipette whole blood and provides clot detection and liquid level detection to increases confidence in sample quality. The reaction disk has ultrasonic mixing which reduces maintenance and carry-over potential.
In addition, the cobas 6000 analyzer series includes cobas e-services, an on- line connectivity solution, which provides customers with fast, direct service, on-line training, and benchmark reporting. cobas link, as a part of e-services, automates manual tasks to keep the analyzer updated with the latest quality control. It also allows for improved troubleshooting and service via remote diagnostics.
The first three of seven configurations will be available for laboratories when the cobas 6000 analyzer series is launched later this summer: the cobas c 501 clinical chemistry analyzer, the cobas e 601 immunoassay analyzer, and the integrated cobas 6000 <501 | 601> analyzer series. Starting this May, the cobas 6000 analyzer series will be on tour from coast to coast. A six-month road show, Connections '06, will travel to 14 cities and will give current and prospective customers insight to the many benefits provided by this new analyzer. Product demonstrations will be given and multiple topics discussed related to the interests of today's laboratory professional.
SOURCE: Roche Diagnostics