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Said: Thanks Jeremy. We were performing 10 QC tests per level, Linearity (duplicate), and 5 patient samples comparing them to the old lot and our main lab analyzer. Would you share what you do?

Said: I don't think there is a specific CAP reg that requires a LOT to LOT study or Cal/Ver a new LOT to be performed on the waived glucometer strips.  However, given that it only takes a ...

Said: If anyone can direct me to the specific CAP or CLIA reg that addresses this, I would be most appreciative!

Said: * What is the use of GEM SYTEM EVALUATOR * Do you run GEM SYSTEM EVALUATOR all the time? If not when do you run the GEM SYSTEM EVALUATOR? Sincerely, Alma “Far and away the best prize that life offers is the CHANCE to work hard at work...

Said: I do not believe there is a requirement for the TEST STRIP itself but there are regulatory requirements that you need to do for the instrument to prove you have done due diligence prior to putting the instrument to use for patient testing. ...