Lot to Lot Validation Glucose Strips

The Allowable Error is +/- 12% for results over 100 mg/dL and +/- 12 mg/dL under 100 mg/dL

Hello
Follow-up questions:  What validation(s) are you performing?  Simple precision, linearity?  Glucose strips waived or moderate complexity??

Where did you get the Allowable Error from CLIA, CAP??

Thank you

To all, 

In the 30+ years I have been in POCT, I have never performed lot to lot on glucose strips for the reasons below.  

let me know if there is a standard that I have missed that requires this. Thanks. 

Thank you for your responses everyone, I am just new in this role and working my way around things. This group is such a big help. 

@Deanna Bogner : thank you for taking time to respond, to answer your question, we are not following a CLIA or CAP requirement

@Elizabeth St Pierre : Thank you, I just found a previous document of what our evaluation criteria is, I am glad to know it's more or less the same as what you said. 

If you are a CAP lab, no need to validate lot to lot if your glucose meter is waived. Those regs have been around for a long time for waived testing.
JoAnn