FDA Grants CLIA-waived status to CoaguChek XS Plus system
Roche announced that it has been granted CLIA-waived status by the FDA for the CoaguChek XS Plus system, a point-of-care anticoagulation monitor that offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing.
The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The CoaguChek XS Plus system offers the ability to connect and transfer data to IT solutions, including TELCOR QML, RALS-Plus with expanded device configuration capabilities or through the POCT1A standard data transfer protocol.
The system uses two-level, built-in quality controls to help ensure the accuracy of PT/INR test results, but also offers optional liquid quality controls for facilities with policies requiring the use of external quality control measures.
For more information call (317) 521-2000 or visit www.roche-diagnostics.us.