IRIS International, Inc. (Nasdaq:IRIS), a leading manufacturer of automated in-vitro diagnostic systems and consumables for use in hospitals and commercial laboratories worldwide and provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the analysis of synovial fluid as a new product application in its Body Fluids Module utilizing its iQ®200 and iRICELL® automated microscopy analyzers.
"This latest approval for synovial fluid analysis, the second-most prescribed body fluid test after cerebrospinal fluid, significantly rounds-out our Body Fluids Module for the analysis of critical body fluids other than urine, and increases the overall clinical utility of our iQ200 and iRICELL series of automated urinalysis microscopy systems," stated Cesar Garcia, Chairman, President and Chief Executive Officer of IRIS. "We now offer a complete body fluids menu including cerebrospinal, pleural, peritoneal, pericardial, general serous and synovial fluids," he added.
"As a result of the frequency of the test, by adding synovial fluid analysis capabilities, we can positively impact manual labor and help to standardize a rather large volume specialty test with minimal workflow interruptions," stated Thomas Warekois, President of the Iris Diagnostics Division. "Body fluids is performed in the majority of our target hospitals and laboratories on the iQ200, and this extended body fluid application allows us to approach additional hospital laboratories for sales of our automated microscopy systems and related consumables, as it may enable hospitals with lower volume of urinalysis tests to justify the purchase of our equipment, instead of continuing the manual microscopy approach."