HB Reading Removed

Updated 1 month ago by Michelle Pool

Recent guidelines issued by the FDA state that glucose meters for over-the-counter use should only display the glucose reading and no other parameters like hematocrit and hemoglobin.

Meters used by physicians and hospitals in a professional setting, on the other hand, can still display these additional parameters.

Keto-Mojo launched a professional grade meter that displayed hematocrit and hemoglobin, offering consumers an enhanced product. However, to comply with recent FDA guidelines, we have started to make the transition to eliminate HCT and Hb from the meter display. In our first step, we made changes to the new glucose strips and now your meter will no longer display hemoglobin.

This in no way affects the accuracy of your glucose reading. Those calculations are still taking place in the background but are not displayed, in accordance with the recent FDA guidelines.

In the upcoming months we will remove the display for both HCT and Hb.

Just for reference, we also try to make it clear in our manuals and instructions that the HCT & Hb measurements are calculations that ensure our very high standard of glucose accuracy, and are not for diagnostic purposes.

For additional information , please refer to the documents below:

FDA. Blood glucose monitoring test systems for prescription point-of-care use.

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM626743.pdf

FDA. Self-monitoring blood glucose test systems for over-the-counter use.

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM626742.pdf

If you have any other questions, please do not hesitate to ask. We are here to help!


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