FDA Clears First Blood Tracking Device that Uses Radio Frequency Identification Technology
WASHINGTON, May 28 -- The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:
iTrace for Blood Centers, (Version 1.0.924.0), 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 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."
RFID is a tool widely used for identification and tracking of various objects. In a typical RFID system, a small memory-storage chip is placed on the item being tracked. RFID readers send and receive radio waves to detect chips and read their data. The iTrace RFID application is designed to augment existing blood bank systems and to work in conjunction with barcode identification and labeling processes currently in place.
iTrace for Blood Centers interfaces through a server with blood establishment computer software to receive and store data used by blood establishments during the manufacturing process, including information related to collection; component processing and labeling, including verifying the product code; expiration date; and blood type (ABO/Rh) information.
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.
iTrace for Blood Centers is manufactured by SysLogic, Inc., based in Brookfield, Wis.
For more information:
* Radio Frequency Identification (RFID) (http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/Electromag...)
* RFID Technology: Protecting the Drug Supply (http://www.fda.gov/Drugs/DrugSafety/ucm169918.htm)
* Premarket Notification (510k) (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarke...)
* CBER 510(k) Process (http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/510...)
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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