Baebies G6PD Enzyme Deficiency Test Gets 510(k) Clearance
The FDA has granted 510(k) clearance to Baebies for its rapid point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, an inherited enzyme deficiency that causes hemolytic anemia.
G6PD deficiency is the most common enzyme deficiency worldwide, affecting approximately 400 million people. The defect causes premature destruction of red blood cells and is a significant cause of jaundice in newborns.
The test is run on the company’s Finder platform, an instrument the size of a toaster that delivers results in approximately 15 minutes and uses a single drop of blood as a sample — very useful for newborn and pediatric testing.
G6PD is the first FDA-cleared test on the company’s platform. Baebies says it plans on adding additional types of tests to the Finder platform.