FDA OKs Trinity Biotech’s Premier Resolution System

Trinity Biotech has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Premier Resolution system, an automated analyzer to quantify hemoglobins F and A2 and detect >200 hemoglobin variants.
 
The lab-based hemoglobin diagnostic system is made of a liquid chromatographic analyzer, reagents, analytical column, and software to allow fractionation and quantitation of fetal hemoglobin (Hb F) and hemoglobin A2 (Hb A2), as well as with fractionation and presumptive identification of abnormal hemoglobin variants.
 
The technology uses the principles of ion-exchange (IEX) liquid chromatography (HPLC) to accomplish this. Premier Resolution is a successor to Trinity Biotech’s Ultra system, which had strong market presence in the U.S. hemoglobin variant diagnostic market
 
The hemoglobin variants that Premier Resolution detects can cause conditions like thalassemias and Sickle Cell disease. Premier Resolution offers labs a tool to easily identify clinically important variants, according to the company.
 
Aris Kekedjian, chairman and CEO of Trinity Biotech told the press, “We welcome the news that our Premier Resolution has received 510(k) clearance from the FDA. Our intention is to regain our market leading position in hemoglobin variant detection with a modern successor to the highly regarded Ultra platform. The Premier Resolution System builds on our Ion Exchange technology reputation for excellence in the separation and identification of a broad range of rare hemoglobin variants. It features a high degree of advanced feature flexibility and a market leading combination of accuracy, speed and value. We also expect this important 510(k) clearance from the FDA to drive further penetration of the Premier Resolution System in key global markets, including Brazil, and allow us to begin the regulatory process for the Chinese market.”
 
“This is an important milestone in the transformation of Trinity Biotech which is anchored by the expansion of our hemoglobin and diabetes franchises,” Kekedjian continued. “The Premier Resolution represents the first in a number of expected product roll-outs and investments in this space, with further product upgrades in our core diabetes HbA1c platform expected to follow in the new year.”