The automated system uses ion exchange HPLC technology to deliver A1c results while detecting common hemoglobin variants.
Tosoh Bioscience Inc has received US Food and Drug Administration 510(k) clearance for its Automated Glycohemoglobin Analyzer HLC-723-GR01, a next-generation system designed for HbA1c testing in clinical laboratories.
The GR01 analyzer is intended for monitoring long-term blood glucose control in individuals with diabetes, aiding in diabetes diagnosis, and helping identify patients who may be at risk of developing the disease.
The fully automated system uses Tosoh’s proprietary non-porous ion exchange HPLC column technology to deliver A1c results in 50 seconds while simultaneously detecting common hemoglobin variants. The analyzer demonstrates precision with coefficients of variation ≤1.1% in NGSP units.
Designed for Mid to High-Volume Testing
The compact analyzer targets both mid and high-volume laboratories, offering high throughput capabilities without the complexity typically associated with larger systems, according to a release from the company. The GR01 features automatic buffer change functionality designed to maintain continuous operation without workflow interruptions.
The system includes walkaway operation capabilities and an intuitive user interface with seamless laboratory information system connectivity. These features are designed to help streamline laboratory workflow processes.
“Our GR01 is the next step in our legacy of world-renowned analyzers for A1c testing. We’re honored to share this system with the community of clinicians working in diabetes management in the United States,” says Jim Shaffer, executive vice president at Tosoh Bioscience, in a release.
Photo caption: Automated Glycohemoglobin Analyzer HLC-723-GR01
Photo credit: Tosoh Bioscience
