Guest guest Posted January 30, 2009 Report Share Posted January 30, 2009 To clarify what standards prodigy used in submitting their meters for f d a approval I asked Tim at prodigy. He was of the opinion but could not say with any authority that the iso 15917 was the operative standard. He agreed that this was different from saying theat iso standard was required in contrast to saying the f d a would accept it in consideration of an application. He could not confirm that the f d a has accepted the iso standard and requires it for all applications. He was a quite friendly person and took all the information and said he would refer my questions to someone who might be able to clarify. I took the oppertunity to mention that some users have noticed a pattern to the accuracy of results that is different then the usual 20 percent variation prodigy uses. I mentioned that as one gets away from central numbers the amount of inaccuracy seems to increase based on the experience of some users in a way in the prodigy as to bring attention to itself. These users were then doing a mental recalibration to take this into account. I suggested it would be in the companies interest to put to rest these observations one way or another if nothing else to ease the user's concerns. He agreed this should be considered and wouldalso be refering this to someone's consideration. For both matters someone would be getting back to me for clarification. One could not ask for anything more and I was entirely satisfied with our conversation. XB IC|XC Quote Link to comment Share on other sites More sharing options...
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