Determining the Appropriate Sampling Regime when Assigning Values to an IVD Device

J

JPPowell

#1
I am part of a team that are looking to develop an IVD reagent kit. Part of the required testing protocols is the value assignment for the calibrators and subsequent verification. Although we are confident with the testing strategy we are planning to adopt, we are unsure of the appropriate sampling regime to adopt to ensure statistical validity.
This involves destructive testing of a sample from discreet lots of 150 to 500 kits per lot.
Can someone advise as to how we determine the sample size to be tested?

Thanks and regards

JP
 
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#2
Re: Determining the Appropriate Sampling Regime when Assigning Values to an IVD Devic

Does anyone have ideas for this?
 
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