IRIS Gets FDA Approval to Use iQ200 Microscopy Analyzers

The U.S. Food and Drug Administration (FDA) has granted the 510(k) clearance for IRIS International, to analyze synovial fluid by using the iRICELL and iQ200 automated microscopy analyzers. The company will analyze the synovial fluid as a product application, in the Body Fluids Module.

Synovial fluid is a sticky material present in many joints of the human body. The fluid lubricates and nourishes certain portions of the joint. Analyzing the synovial fluid aids in diagnosing the cause of fluid accumulation, as well as joint swelling, pain, and inflammation. These symptoms are associated with disorders such as systemic lupus erythematosus, rheumatoid arthritis, and chronic and acute septic arthritis.

The Body Fluid Module is provided as an individual software choice for the iQ200 microscopy analyzer, for evaluating automated body fluids. The module allows a lab to examine a collection of urine samples and body fluids, on its current iQ200 analyzer with the help of the digital imaging technology of IRIS.

The iQ200 microscopy analyzer, in combination with the IRIS’ iChem VELOCITY automated chemistry analyzer, creates the iRICELL workstation. This combination offers an automated system for controlling the workload of urine chemistry testing, urine microscopy testing, and body fluids analysis.