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# FDA Clears Tosoh’s Next-Generation HbA1c Analyzer
- URL: https://www.fdaweb.com/fda-clears-tosohs-next-generation-hba1c-analyzer/
- Published: 2025-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:25:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160138

FDA has cleared a Tosoh Bioscience 510(k) for its next-generation Automated Glycohemoglobin Analyzer, the HLC-723 GR01, for rapid and precise HbA1c (blood sugar) testing. The new system can deliver results in as little as 50 seconds, supporting both diabetes diagnosis and long-term glucose monitoring, according to the company. Using Tosoh’s proprietary non-porous ion-exchange HPLC technology, the GR01 provides accurate and consistent measurements, including detection of hemoglobin variants, across a wide range of patient samples, it says.