The Blood Creatinine Meter M421 has become the first home-use rapid blood creatinine testing product from China to receive the U.S. Food and Drug Administration (FDA) "Breakthrough Device" designation. This recognition places the M421 among the world's top technological innovations.
The FDA "Breakthrough Device" designation is a hallmark of cutting-edge technological innovation on a global scale. Previous recipients include leading medical technology companies such as Johnson & Johnson, Abbott, Medtronic, and Boston Scientific, known for their advanced products. The PM-M421 Creatinine Meter, recognized for its original materials, proprietary technology, and innovative design, is a significant achievement.
To qualify for the FDA "Breakthrough Device" designation, a product must meet key criteria: it must be a globally original technology that offers more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, with no approved or alternative solutions available, or it must offer significant advantages over existing solutions. The device's availability must also align with the best interests of patients.
Chronic kidney disease (CKD) is a significant global public health issue due to its high prevalence, low awareness, poor prognosis, and high medical costs. As kidney function declines, CKD patients face significantly increased risks of cardiovascular events and death. When CKD progresses to end-stage renal disease, patients depend on dialysis or kidney transplantation for survival, imposing a heavy economic burden on families and society. Therefore, finding effective prevention, scientific management, and strategies to slow CKD progression is a global challenge.
The M421 5-in-1 meter, capable of measuring creatinine, blood glucose, uric acid, hemoglobin, and glomerular filtration rate, aids in the management of kidney health for CKD patients and high-risk groups, such as those with hypertension, diabetes, and hyperuricemia. It also provides a convenient kidney disease management solution for hospitals, communities, clinics, and nursing homes.
Advantages:
Rapid Results: Blood glucose results in 5 seconds, uric acid in 10 seconds, and creatinine in 30 seconds.
Patient-Friendly: Requires only 3-5 microliters of capillary blood from a fingertip.
Multi-Parameter Testing: Integrated with a mobile app, it helps patients manage health metrics and allows family members to monitor the health of elderly parents.
Patented Technology & Innovative Algorithms: Offers higher accuracy and stronger anti-interference capabilities, with results nearly identical to hospital tests.
interested click:Blood Creatinine Meter 5 in 1 Creatinine Blood Glucose Uric Acid HbA1c eGFR*