Tosoh Bioscience Receives FDA 510(k) Clearance for Fast, Accurate GR01 HbA1c Testing Analyzer

Original from: PR Newswire

Tosoh Bioscience, Inc., a market leader in clinical diagnostics has received U.S. FDA 510(k) clearance for its next-generation Tosoh Automated Glycohemoglobin Analyzer HLC®-723 GR01 (GR01) for HbA1c testing.

The GR01 Analyzer is designed for both diabetes diagnosis, identifying those at risk of developing diabetes, and long-term glucose monitoring, offering fast, precise, and reliable HbA1c results in just 50 seconds. Using Tosoh's proprietary non-porous ion-exchange HPLC technology, the GR01 delivers consistent accuracy and variant detection in every sample — supporting clinical confidence across diverse patient populations.

High-Speed Precision for Modern Laboratories

Compact yet powerful, the GR01 meets the needs of mid- to high-volume laboratories. It offers the throughput of a high-capacity system with streamlined operation, automatic buffer changes, and walkaway functionality to maximize efficiency and reduce hands-on time. The analyzer's intuitive touchscreen interface and LIS connectivity simplify workflow integration.

Accuracy You Can Trust

Delivering CVs ≤ 1.1% (NGSP Units), the GR01 provides reproducibility and reliability — helping clinicians make confident diagnostic and therapeutic decisions in diabetes management.

"The GR01 represents Tosoh's next leap forward in HbA1c testing — combining speed, precision, and simplicity in one compact system," said Shunsuke Kinoshita, President, Tosoh Bioscience, Inc. "It reaffirms our commitment to advancing diagnostic solutions that support better patient outcomes."

Source: Tosoh Bioscience Receives FDA 510(k) Clearance for Fast, Accurate GR01 HbA1c Testing Analyzer