FDA Grants CLIA-Waived Status to CoaguChek XS Plus System for INR Testing

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy


October 8, 2012
CoaguChek XS Plus System Point of Care Testing Blood Testing

October 8, 2012 — The U.S. Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA)-waived status to the Roche CoaguChek XS Plus system. The point-of-care anticoagulation monitor 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 CLIA of 1988.

"The waived status of CoaguChek XS Plus system allows healthcare professionals in CLIA-waived environments access to new tools and connectivity options to help them manage patients on warfarin therapy," said Rod Cotton, senior vice president, professional diagnostics, physician office laboratory, and medical and scientific affairs, at Roche Diagnostics Corporation. "The technology has several features that help ensure fast, accurate results, and the connectivity capabilities help healthcare providers with regulatory compliance, making it easier for them to manage their anticoagulation practices."

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. Implementing connectivity with the CoaguChek XS Plus enables data transfer and reporting capabilities to help hospital staff streamline the regulatory compliance process, capture reimbursable costs and improve their organizational efficiency.

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: www.roche.com or www.roche-diagnostics.us.