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Roche Says FDA Grants CLIA-waived Status To CoaguChek XS Plus System

10/1/2012 11:25 AM ET

Roche (RHHBY.PK) announced Monday that the U.S. Food and Drug Administration or FDA has granted CLIA-waived status to 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 or CLIA of 1988.

The company stated that 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 company said.

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.

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by RTT Staff Writer

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