If handheld blood glucose meters were always as accurate checking blood sugar levels as the much bigger (25 pounds), much more expensive ($10,000) analyzers that hospitals and labs use, then hospitals and labs would use the small, personal blood sugar meters. Find out more about how meters get to market, what to look for when choosing your next meter, and how to calculate the performance results of the meter you have now.
How meters get to market
To get clearance to market a new meter, a manufacturer needs to submit data to the U.S. Food and Drug Administration (FDA) that shows the new blood glucose monitoring system (meter plus test strips) is as safe to use and effective as other devices on the market that have FDA clearance.
Many meter companies cite criteria published by the International Organization for Standardization (ISO), a network of the national standards institutes of 162 countries, based in Switzerland. The standard for blood glucose meters is ISO 15197, published in 2003. It is an FDA-recognized standard. It includes instructions for manufacturers on how tests of accuracy are to be run and what counts as a passing grade.
Companies don't have to go by the ISO standard. According to the FDA, "Conformance with recognized consensus standards is strictly voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner."
So if a manufacturer isn't using the ISO standard, it still has to make a case to the FDA that the device and strips are as safe to use and effective as others on the market.