FDA clears Roche's CoaguChek XS Pro
This article was originally published in Clinica
Executive Summary
Roche Diagnostics' latest point-of-care (POC) anticoagulation monitor, the CoaguChek XS Pro, has received 510(k) clearance from the US FDA. The device assesses prothrombin time (PT) and the international normalised ratio (INR), which are measures of blood clotting tendency. This information can be used to adjust doses of the anticoagulant drug warfarin. The meter has a built-in bar code reader that can automatically scan information to identify operators and patients, in conjunction with the firm's RALS-Plus information management system. This could prevent the errors sometimes generated when clinicians manually enter information on PT/INR, Roche says. The system requires 8 microlitres of blood, and can provide results in around one minute, the firm added.