Tosoh Announces 510k Clearance for Highly Anticipated Next-Generation GR01 HbA1c Analyzer: A Fast, Accurate and Efficient Solution for A1c Testing

GROVE CITY, Ohio, Oct. 6, 2025 /PRNewswire/ -- Tosoh Bioscience, Inc., a market leader in clinical diagnostics is proud to announce that it has received US FDA 510(k) clearance for its next-generation system for HbA1c testing - the Tosoh Automated Glycohemoglobin Analyzer HLC®723-GR01 (hereafter "GR01"). The GR01 is intended for monitoring the long-term blood glucose control of individuals with diabetes, as an aid in the diagnosis of diabetes and to help identify those who may be at risk of developing the disease.

With a compact footprint, the GR01 is a fully automated analyzer that harnesses Tosoh’s proprietary non-porous ion exchange HPLC column technology to deliver precise, reproducible A1c results in just 50 seconds — while also detecting the most common hemoglobin variants.

The system delivers excellent precision with CVs ≤ 1.1% (NGSP Units). This provides clinicians with higher confidence while diagnosing and managing diabetes.

The GR01 is an ideal solution for both mid and high volume laboratories, offering the speed and efficiency of a high throughput system without the complexity or size typically associated with large analyzers. The analyzer’s automatic buffer change feature keeps the lab running smoothly with no workflow delays.

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