The FDA requested “inaccuracy” warning signs on Prodigy glucose meter – a smart way to enforce accuracy. (Source: http://www.accessdata.fda.gov/cdrh_docs/reviews/K122340.pdf)
—- From the FDA document: ———————————
For glucose concentrations > 75 mg/dL, 95% of the results shall be within ± 20%.
It is at least encouraging that the FDA is really pushing for a higher standard. As I express throughout this website, I really feel that accuracy should be the most important criterion for assessing a glucose meter, and unfortunately, it happens to be a criterion that is often overlooked by users.
I believe that the FDA will most likely try to adhere to the new ISO standard, which requires that 95% of glucose readings have to fall within a 15% error from the true glucose value when the glucose concentration is above 100 mg/dl, or within +/- 15 mg/dl error from true glucose values when the glucose concentration is below 100 mg/dl. Since Prodigy’s data have shown that only 78% of the data fall within the +/- 15% criteria (>10 mg/dl), their device is pretty inaccurate.
Users can look at our Glucose Meter Reviews chart to determine which meter is the most accurate, and compare the Prodigy Choice meter with the other meters we chose to review in this website. We hope this information can be useful.