Micronics Receives 510(k) Clearance to Market ABORhCard® for Blood Group Determination
REDMOND, Wash., USA (May 4, 2010) – BusinessWire – Micronics, Inc., a medical device development company today announced that the U.S. Food and Drug Administration has granted the company 510(k) clearance to market its ABORhCard, a qualitative in vitro test that provides a simultaneous determination of an individual’s ABO blood group and Rh factor status. It is not for use for blood bank processing of blood products, for determining RHD status for the purpose of administration of Rh immunoglobulin, or for screening purposes prior to transfusion. The device is intended for single use for individual blood group determination for educational and informational purposes.
Blood typing typically focuses on determining a person’s blood type (either A, B, AB or O) and Rhesus (Rh) factor. A person’s blood type is based upon the presence or absence of the A and B antigens on their red blood cells. For example, the A blood type has only the A antigen, and the B blood type has only the B antigen. The AB blood type has both A and B antigens, while the O blood type has neither A nor B antigen. In routine blood typing, testing for the D antigen, known as the Rh factor, is performed. If the D antigen is present, the person is Rh positive (Rh+); if the D antigen is negative the person is Rh negative (Rh-).
“The introduction of the ABORhCard provides professionals with access to a credit card-sized device that makes it possible to determine a person’s blood type and Rh status from a finger stick of whole blood, and it provides a visually-read result in minutes,” said Karen Hedine, president and chief executive officer of Micronics.
According to the most recent U.S. National Blood Collection and Utilization Survey, over 28% of blood donations are from first time donors, and 10-20% of all donations are from individuals under 20 years of age.
Knowledge of donor blood type prior to donation may assist collection staff at blood donor centers in guiding donors to the most appropriate donations and empower individuals to choose the type of donation most suited to meeting blood supply demands.
Benefits of the ABORhCard
The ABORhCard is a single use, disposable device that incorporates the necessary blood typing reagents. While other manual methods for blood typing are available, such products and methods generally either require liquid reagents that need refrigeration or their use is open to the environment. In comparison, the ABORhCard is a closed system that is stored at room temperature and provides a user friendly, integrated test that produces a visible result in minutes following collection of a small sample of blood. The ABORhCard is believed to be the first 510(k) cleared test of its type to have undergone extensive U.S. clinical trials. Micronics enrolled 1700 volunteers at studies performed by three U.S. blood centers before submitting the 510(k) pre-market notification to the FDA’s Center for Biologics Evaluation and Research.
The ABORhCard was developed in part under funding from the U.S. Army Medical Research and Materiel Command (USAMRMC) and the Telemedicine and Advanced Technology Research Center (TATRC), Fort Detrick, Maryland 21702. TATRC identified a requirement for a field-deployable test for pre-screening of potential blood donors as part of a new service member’s health profile, and a device to assist in managing large volumes of donors in contingency operations to include national emergencies, mobilization or war.
Micronics is a leading developer of custom product development for clients worldwide in addition to advancing its own game changing medical devices for patient-centric immunohematology and molecular diagnostic infectious disease testing. The Company has developed a significant patent estate in microfluidics – the ability to substantially reduce the reagents and sample volumes required to process a diagnostic test – together with related technologies that enable the direct processing of biological and environmental samples, and the performance of highly accurate tests in a fraction of the time required by most molecular diagnostic tests in use today.
The Telemedicine & Advanced Technology Research Center (TATRC) performs medical reconnaissance and special operations to address critical gaps that are underrepresented in DoD medical research programs. TATRC is an office of the headquarters of the US Army Medical Research and Materiel Command (USAMRMC). TATRC fosters research on health informatics, telemedicine/m-Health, medical training systems, and computational biology, and promotes and manages science and engineering in other key portfolios. Through an extensive network of partners, TATRC is focused at both ends of the research spectrum, exploring models of high risk and innovative research, and putting research findings into the hands of warfighters while looking toward wider civilian utility. TATRC augments core medical research programs through special funding and partnership opportunities. For more information, visit us at: www.tatrc.org
The views, opinions and findings contained in this research are those of Micronics, Inc. and do not necessarily reflect the views of the Department of Defense and should not be construed as an official DOD/Army policy unless so designated by other documentation. No official endorsement should be made.