IRIS International has commenced the shipment of iChemVelocity Automated Urine Chemistry Analyzers in combination with iRICELL Urinalysis Workstations to three US hospitals, following 510(k) market clearance from the US Food and Drug Administration (FDA) on 24 March.
The iChemVelocity system is designed to deliver improved productivity and clinical utility in the medium to high volume hospital and clinical reference labs.
Iris Diagnostics Sales America vice president Ken Waters said this next generation of Iris automated urinalysis systems combines their series of leading iQ 200 automated urine microscopy analyzers with the iChemVelocity automated urine chemistry analyzer in two new product configurations, iRICELL Plus with optional iWare software and iRICELL PRO.
"We are committed to continuing to support our US installed base of approximately 1200 iQ200 urinalysis workcell systems, and we believe this new product line will continue to generate strong demand for the Iris automated urinalysis solution," Waters said.
IRIS International chairman, president and CEO Cesar Garcia said they will immediately begin the registration process in those international countries which require regulatory approval in the country of origin, allowing them the opportunity to gain full access and further penetrate a significant portion of the estimated $500m worldwide urine chemistry market.
"This will result in improved gross margins and significantly increase the pull-through of chemistry reagents and iChem test strips, improving the utilization of our strip manufacturing facility in Marburg, Germany, which is already operating near breakeven," Garcia said.
While it was pursuing US regulatory clearance, IRIS received CE mark certification and launched the iChemVelocity to the international marketplace in September 2008.