NEW YORK – Irish diagnostic company Trinity Biotech announced on Monday that it has received 510(k) clearance from the US Food and Drug Administration for its Premier Resolution System automated analyzer.
The platform quantifies fetal hemoglobin and hemoglobin A2 and detects more than 200 hemoglobin variants, the company said in a statement. It includes a liquid chromatographic analyzer, reagents, an analytical column, and software to allow for the fractionation and quantitation of hemoglobins F and A2, as well as the fractionation and presumptive identification of abnormal hemoglobin variants.
The new instrument is a successor to Trinity Biotech's previous Ultra System, the Dublin-based firm noted. The FDA clearance is expected to "drive further penetration" of the instrument in global markets like Brazil and will allow the company to begin the Chinese regulatory process, Trinity Biotech Chairman and CEO Aris Kekedjian said in a statement.
"This is an important milestone in the transformation of Trinity Biotech, which is anchored by the expansion of our hemoglobin and diabetes franchises," Kekedjian added. "The Premier Resolution represents the first in a number of expected product rollouts and investments in this space, with further product upgrades in our core diabetes HbA1c platform expected to follow in the new year."