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FDA clears IRIS synovial fluid analysis with automated microscopy analyzers

IRIS International, a manufacturer of automated in-vitro diagnostic systems, has received US Food and Drug Administration (FDA) 510(k) clearance for the analysis of synovial fluid as a new product application in its body fluids module utilising its iQ200 and iRICell automated microscopy analyzers.

The iQ200 analyzer is provided with a module as a separate software option for automated body fluids analysis which is expected to generate incremental recurring revenue through the use of the company’s consumables.

The application enables a laboratory to analyse a suite of body fluids and urine samples on its existing iQ200 instrument using the company’s patented digital imaging technology.

The iQ200, when combined with the iChemVelocity automated chemistry analyzer, forms the iRICell workstation, providing an integrated and automated system for managing the workload of urine microscopy and urine chemistry testing, as well as body fluids analysis.

IRIS chairman, president and CEO Cesar Garcia said that this latest approval for synovial fluid analysis rounds-out body fluids module for the analysis of critical body fluids other than urine, and increases the overall clinical utility of iQ200 and iRICell series of automated urinalysis microscopy systems.

“We now offer a complete body fluids menu including cerebrospinal, pleural, peritoneal, pericardial, general serous and synovial fluids,” Garcia said.