The approval is likely a big issue. The manufacturer can buy the approved strips, and claim that they are validated and accurate. How much paperwork you need to

The approval is likely a big issue. The manufacturer can buy the approved strips, and claim that they are validated and accurate. How much paperwork you need to submit for the digital part is an interesting question. I would expect you do need to validate it, but sometimes there are loopholes that allow you to claim it is not a medical device. Building a phone app to interpret the stripes would be so much less wasteful, but where is the money in that…