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FDA Grants CLIA-Waived Status To Roche Diagnostics CoaguChek XS Plus System

Roche Diagnostics has received CLIA-waived status from FDA to 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 is the monitoring technology that can be used in a broader range of clinical settings, such as labs that do not meet the requirements to do moderate- or high-complexity testing as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

The CoaguChek XS Plus system works with the RALS-Plus information management system, which provides reporting and device management capabilities, to help hospital staff streamline the regulatory compliance process, capture reimbursable costs, and improve their organizational efficiency. In addition, recent enhancements to the system include the ability to hold up to 1000 patient results and the reduction of the sample size requirement to 8ml.

The CoaguChek XS Plus 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.

Tim Huston, director of marketing, professional diagnostics physician office laboratory at Roche Diagnostics, said: “With the waiver for the CoaguChek XS Plus system, healthcare professionals in CLIA-waived environments will now have access to new tools and connectivity options to help them manage patients on warfarin therapy.

“The technology has several features that help ensure fast, accurate results, and the connectivity capabilities help healthcare providers with regulatory compliance and make it easier for them to manage their anticoagulation practices.”