SHINVA SGH-400 HbA1c Analyzer Earns Prestigious IFCC Certification

On July 29, 2025, SHINVA’s independently developed SGH-400 Fully Automated Glycated Hemoglobin Analyzer successfully obtained certification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).

This achievement signifies that SHINVA SGH-400 has received authoritative international recognition for its technological innovation and testing accuracy, providing solid support for precise diagnosis and monitoring of diabetes treatment.

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established the HbA1c Standardization Working Group in 1995 to develop a high-level metrological reference system for the standardization and calibration of HbA1c testing. The goal is to align results with the NGSP network and achieve global comparability of HbA1c measurements.

The SGH-400 analyzer demonstrated outstanding performance in rigorous multicenter evaluations, showing high consistency with IFCC reference methods. This ensures global comparability and credibility of test results. The IFCC-certified SGH-400 can assist clinicians in developing more precise treatment plans and reducing misdiagnosis risks caused by testing discrepancies.

SHINVA SGH-400 utilizes the 'gold standard' high-performance liquid chromatography (HPLC) method, which significantly improves accuracy. With a testing time of only 60 seconds per sample, it is especially suitable for mass screening and long-term diabetes management. Recognized for its excellent stability, accuracy, and user-friendly operation, the SGH-400 has gained increasing market acceptance and is widely used in physical examinations, clinical diagnostics, and treatment monitoring for diabetes.

SHINVA will continue to uphold its innovation-driven strategy, increase R&D investment, and enhance product performance and quality, delivering high-quality IVD products and solutions to support the advancement of global healthcare.