Micronics receives FDA marketing clearance for ABORhCard

May 4 2010

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.

“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”

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.