Ortho Clinical Diagnostics announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS® 3600 Immunodiagnostic System.
The VITROS® 3600 Immunodiagnostic System combines three proven VITROS® technologies into a single system, designed to consistently produce highly accurate test results:
· MicroWell Technology with enhanced chemiluminescence enables exceptional assay performance with small sample volume requirements across a broad range of diseases.
· MicroSensor Technology automatically performs sample quality indices checks for the first time ever on an immunoassay system. This capability reduces the time, labor and error potential of manual interpretation.
· Intellicheck® Technology verifies analytical performance and reduces error potential by providing real-time operator notification and tracking.
Additionally, the processing speed, on-board reagent capacities and uninterrupted workflow advantages of the system allow laboratories to address peak workloads and decrease turnaround times.
“One of the key challenges faced by diagnostic laboratories today is the need to decrease the turnaround time required to provide accurate and reliable test results to clinicians. The intelligent sample management capabilities of the VITROS® 3600 Immunodiagnostic System allow users to increase productivity while maintaining high-quality test results,” said Denise Uettwiller-Geiger, Ph.D., Administrative Director and Director of Clinical Research at John T. Mather Memorial Hospital in Port Jefferson, N.Y. “The large capacity of 31 reagent packs and the ability to change reagents and consumables, as well as offload waste while the VITROS® 3600 Immunodiagnostic System is operating, provides uninterrupted workflow to ensure we can keep up with testing demands.” Dr. Uettwiller-Geiger is a principal investigator for the VITROS® 3600 Immunodiagnostic System.
The VITROS® 3600 Immunodiagnostic System can be easily integrated with the enGen™ Laboratory Automation System and other VITROS® Systems, such as the VITROS® 5,1 FS Chemistry System, allowing users to easily expand or change modules and interfaces as their needs change.
“The introduction of the VITROS® 3600 Immunodiagnostic System continues our commitment to go beyond merely improving existing technologies to help clinical laboratories meet their challenges,” said Ortho Clinical Diagnostics Worldwide Commercial President Mark Straley. “We built this new high-capacity system based on a foundation of proven VITROS® technologies to give our customers the ability to consistently produce highly accurate test results for high-volume routine immunoassays, such as cardiology, thyroid and endocrinology, and infectious disease immunoassays, such as HIV and hepatitis.”