Diabetes monitoring system provides lower volume laboratories with high end performance
Bio-Rad Laboratories has received 510(k) clearance from the FDA (Food and Drug Administration) for its D-10 Hemoglobin A1c system which includes both the D-10 instrument and Hemoglobin A1c test kit.
This compact, affordable and fully automated system provides the same level of precision and throughput offered in the company's larger Hemoglobin A1c monitoring systems.
"We are pleased to be able to provide medium and low volume laboratories with the same gold standard technology we offer to higher volume labs," said Bio-Rad vice president of clinical diagnostics, John Goetz.
"The high quality results produced by this Hemoglobin A1c monitoring technology are critical to the effective care of patients with diabetes".
Diabetes affects more than 150 million people worldwide and this number is expected to double within the next 25 years, according to the World Health Organization.
Close monitoring of Hemoglobin A1c levels can lead to better long-term management of patient glucose levels and up to a 40 percent reduction in health complications associated with this disease.
