Blood Ketone Meters

Blood measurement of beta-hydroxybutyrate is the gold standard for ketone testing used by clinicians and researchers. Blood BHB values can be correlated to ISO reference standards, providing a quantitative baseline that urine and breath methods cannot match. Combined ketone-and-glucose blood meters are classified as Class II medical devices and held to a high regulatory accuracy standard. Relevant certifications for blood ketone meters include FDA clearance, CE marking, and MD SAP certification, and manufacturing facilities are subject to FDA inspection. An error in blood meter data could cause a hypoglycemic episode in insulin-dependent patients who use the readings to adjust dosing.