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Following the successful FDA clearance of the MQ-3000/MQ-3000PT HbA1c Analysis Systems, Medconn has announced another major milestone: the MQ-8000/MQ-8000PT HbA1c Analysis Systems have officially received FDA 510(k) clearance.

With this achievement, Medconn has become the first Chinese brand in the industry to have two of its core HPLC-based HbA1c product lines successfully obtain FDA clearance consecutively. This milestone represents a significant achievement for China's IVD industry and highlights Medconn's growing capabilities in the global HbA1c diagnostics market.

Not a One-Time Achievement, but a Demonstration of Sustained Innovation

In January 2026, Medconn's independently developed MQ-8000/MQ-8000PT HbA1c Analysis Systems successfully obtained FDA 510(k) clearance in the United States.

FDA clearance is widely recognized as one of the most demanding regulatory pathways in the medical device industry, with rigorous requirements covering analytical principles, precision, stability, clinical performance, and quality systems.

Medconn's consecutive clearances—from the MQ-3000 Series to the MQ-8000 Series—represent far more than an isolated product achievement. They demonstrate the strength and maturity of Medconn's integrated R&D, quality management, and analytical methodology capabilities.

This milestone means:

·Medconn's HPLC-based HbA1c testing technology has received consecutive recognition from one of the world's most rigorous medical device regulatory systems.

·Chinese IVD brands are no longer simply alternatives to international products, but are increasingly equipped with the technological capabilities to compete alongside leading global brands.

·For Medconn, these achievements represent an important milestone in strengthening brand confidence and advancing Chinese HbA1c diagnostics into international markets.

HPLC Methodology: Elevating the HbA1c Testing Experience

Building on Medconn's extensive expertise in ion-exchange high-performance liquid chromatography (HPLC), the MQ-8000/MQ-8000PT HbA1c Analysis Systems are designed to meet the demanding requirements of advanced clinical laboratories and research applications.

Key Features

·High Precision: Repeatability with a CV of ≤1%, exceeding applicable national standards and supporting high-end laboratory and research applications.

·Advanced Variant Identification: Effectively separates and flags seven common hemoglobin variants, including HbS, HbC, HbD, HbE, and HbJ, helping reduce the risk of inaccurate results associated with hemoglobin variants.

·Direct LIS Connectivity: Chromatographic results can be transferred directly to the Laboratory Information System (LIS), facilitating result review and quality traceability.

·Fast and Flexible Testing: With a fastest testing time of 45 seconds per sample, the system offers three intelligent testing modes to balance efficiency and analytical performance.

·Scalable Automation: Multiple analyzers can be connected for integrated operation, enabling flexible configuration of the Medconn Honeycomb Automation Line to accommodate high-volume testing.

·Intuitive Industrial Design: A large touchscreen and clear displays for sample capacity and STAT positions make key operating information readily visible.

·International Standardization: With both NGSP and IFCC certification, the system supports internationally comparable HbA1c results and is well suited for diabetes diagnosis and long-term glycemic monitoring.

Consecutive FDA Clearances: Taking Chinese HbA1c Diagnostics Global

From the MQ-3000 Series to the MQ-8000 Series, Medconn's consecutive FDA clearances demonstrate a clear evolution in the capabilities of Chinese HbA1c diagnostics.

Chinese HbA1c solutions are no longer simply catching up with the global market. They are increasingly demonstrating the technological strength and quality standards needed to compete on the international stage.

For Medconn, this achievement represents not only a milestone for the company, but also an important step forward for Chinese IVD innovation as it enters the global high-end diagnostics market.

Looking ahead, Medconn will continue to build on the reference-standard HPLC methodology, pursuing greater precision, higher testing capacity, and broader clinical applications.

The world is taking notice of the capabilities of Chinese HbA1c diagnostics—and Medconn is ready for the next stage.