Roche's anticoagulation monitor gets 510(k) clearance
Roche Diagnostics has received 510(k) clearance from the U.S. FDA for the CoaguChek XS Pro system, a point-of-care anticoagulation monitor with a built-in barcode reader that can capture operator and patient identification information.
The barcode reader works in conjunction with the RALS-Plus information management system to help healthcare professionals save time and prevent errors that could occur from manually entering the information for PT/INR (blood clotting time) testing with patients on warfarin therapy, the Basel, Switzerland-headquartered Roche stated.
The newest member of the CoaguChek XS family of meters, the CoaguChek XS Pro system requires a small sample of blood and provides test results in about one minute. Using built-in quality controls and offering the option to run two levels of additional liquid controls, the meter can store up to 1000 patient results and 500 optional liquid quality control results while the operator has the option to enter comments related to either type of result.
The CoaguChek XS Pro system also offers connectivity and data management capabilities by communicating via its optional handheld base unit with the RALS-Plus information management system. The connectivity enables several reporting and device management features, the company added.
The barcode reader works in conjunction with the RALS-Plus information management system to help healthcare professionals save time and prevent errors that could occur from manually entering the information for PT/INR (blood clotting time) testing with patients on warfarin therapy, the Basel, Switzerland-headquartered Roche stated.
The newest member of the CoaguChek XS family of meters, the CoaguChek XS Pro system requires a small sample of blood and provides test results in about one minute. Using built-in quality controls and offering the option to run two levels of additional liquid controls, the meter can store up to 1000 patient results and 500 optional liquid quality control results while the operator has the option to enter comments related to either type of result.
The CoaguChek XS Pro system also offers connectivity and data management capabilities by communicating via its optional handheld base unit with the RALS-Plus information management system. The connectivity enables several reporting and device management features, the company added.