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Lifotronic’s H100Plus Hemoglobin Testing System recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under submission number K260468, allowing the system to be marketed in the United States. This clearance marks an important milestone in the global expansion of Lifotronic’s HbA1c business, reflecting the company’s continued commitment to innovation and international growth.
 

45-Second Analysis to Support Efficient, Reliable Testing

Using ion-exchange high-performance liquid chromatography (HPLC), H100Plus delivers HbA1c results with an analysis time of 45 seconds. Results are traceable to the IFCC reference measurement system and aligned with NGSP standardization.

H100Plus separates and identifies common hemoglobin variants, providing chromatographic information to help laboratories identify samples requiring further review. The system is also listed in the NGSP HbA1c assay interference table. Under the study conditions reported, no clinically significant interference was observed from HbC, HbS, HbE, or HbD traits, providing supporting evidence for reliable HbA1c reporting.

Automatic sample mixing helps ensure sample homogeneity, while the HGB module controls the hemoglobin concentration of the sample introduced into the analytical system. A dual-reagent backup design further reduces manual intervention and testing interruptions, supporting laboratory efficiency and consistent analytical performance.
 

End-to-End In-House Development for Long-Term Growth

From instruments and reagents to chromatography columns and software algorithms, Lifotronic has established an integrated system for the in-house development, manufacturing, and supply of its HPLC-based HbA1c products. Control over core technologies supports continuous product improvement and dependable supply, strengthening the company’s foundation for long-term growth in global markets.

Building on this FDA 510(k) clearance, Lifotronic will continue to advance its core technologies and expand its global presence, delivering efficient, reliable HbA1c testing solutions to clinical laboratories worldwide and bringing Chinese innovation to global diabetes care.