“The iTrace for Blood Centers device has the ability to enhance blood safety by helping to ensure that unsuitable units are not released,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “iTrace for Blood Centers will be used in blood establishments by trained personnel as a tool in streamlining blood collection and processing and aiding in product tracking and reconciliation.”
Read the press release here
S3Edge is proud to announce that iTrace for Blood Centers, the first application to use Radio Frequency Identification (RFID) technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by the U.S. Food and Drug Administration. The device was cleared for marketing based on the submission of a premarket notification, often referred to as a 510(k). A 510(k) submission made to the FDA demonstrates that the device is at least as safe and effective as, that is, substantially equivalent to, a legally marketed device that is not subject to a premarket application.
This is a significant milestone in the commercialization of iTrace for Blood Centers (developed and owned by S3Edge as part of the Transfusion Medicine RFID Consortium – read more here), and we look forward to working with Blood Centers and Hospitals world-wide to deploy this key piece of technology to keep our blood supply safe, secure, and operationally efficient.
The entire S3Edge and TMRFID team.