Development of a Hand Held Thromboelastograph.

摘要

The project objective is to develop a hand-held, ultra-portable thromboelastograph, ready for submission for FDA 510(k) clearance for clinical assessment of coagulation. Entegrion has designated the device as the Portable Coagulation Monitor (PCM). This research effort demonstrated the successful evaluation of the clot dynamics of untreated whole blood samples employing viscoelastic coagulation testing using the novel PCM technology. The PCM produced the results of these tests in the form of a graphic tracing of clotting activity consistent with thromboelastographs generated by other viscoelastic testing instruments currently in clinical use. The PCM technology completed the coagulation tests without the use of reagents or the need for pipetting samples, and using a low-cost instrument designed for ease of use, reduced operator to operator variability, resistance to vibration, humidity and temperature control, in a hand held form. The time to result was reduced as compared to existing viscoelastic coagulation testing instruments. Entegrion believes the PCM is well suited to accommodate additional types of tests on a single handheld platform based on the core PCM technology. Meetings with FDA have clarified the path to completion of a 510(k) premarket notification to the FDA.