FDA grants 510(k) clearance for Ortho Clinical Diagnostics’ ORTHO VISION Max

24 October 2016 (Last Updated October 24th, 2016 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ortho Clinical Diagnostics to market its fully automated blood analyzer, ORTHO VISION Max.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ortho Clinical Diagnostics to market its fully automated blood analyser, ORTHO VISION Max.

The ORTHO VISION Max constitutes a part of the ORTHO VISION platform which has been developed to improve workflow and standardise systems and processes, thereby assisting blood banks to cater to the demand to increase productivity while remaining operationally efficient.

Ortho Clinical Diagnostics chief operating officer Robert Yates said: "Labs are continuously pushed to accomplish more with fewer resources including staff and Ortho can now ease those pressures in labs of every size and makeup.

"Whether they perform 15 tests per day or 150, the ORTHO VISION platform helps labs better manage their contribution to the overall critical-care path."

ORTHO VISION Max can enable labs to conduct more than 50 types and screens in a day while supporting more complex immunohematology testing such as serial dilutions for titration studies, reflex tests and selected cell antibody identification.

"Whether they perform 15 tests per day or 150, the ORTHO VISION platform helps labs better manage their contribution to the overall critical-care path."

The system features flexibility and responsiveness in its operation which allows transfusion medicine department to process routine samples and STAT orders as they are received instead of waiting for a complete batch before running the instrument.

Ortho Clinical Diagnostics transfusion medicine head Heidi Casaletto said: "A comprehensive portfolio of products operating on a single platform means engaging with one user interface, ordering one set of consumables, one set of process and procedures and streamlining training for everyone in the department.

“It also means more rapid delivery of actionable results that would increase the efficiency of patient diagnosis and a recommended treatment plan."


Image: ORTHO VISION Max. Photo: courtesy of Ortho Clinical Diagnostics.