IVD Accuracy and Precision Acceptance Criteria

DanMann

Involved In Discussions
#1
Hi all,

How do you determine acceptance criteria for the accuracy and precision of a diagnostic test/instrument?

My company is designing a blood cell counter and we have purchased a series of standards (EN 20391-1 and -2 and the relevant CLSI standards) so we can ensure we are determing the method's accuracy, precision, lineraity, bias etc. and I think we can design the experiments to do this, but none of the standards we have nor any guidelines I can find give us an idea of the acceptable levels for these.
510(k) submissions to the FDA show the actual levels for other similar products, but none of them provide any guidance on what the acceptable level would be or how to determine it.
Does anyone have any advice on how to determine what level of accuracy or precision is acceptable for a particular product?

TIA
 
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shimonv

Trusted Information Resource
#2
Your first source of information is International standards and guidance documents.
If you cannot find anything there, you can aim to be equal to or better than your predicate device. I parallel to do that you should do a clinical literature review and build a risk analysis. These will help you understand the boundaries, risks, and necessary mitigations to include with your product.

-Shimon
 
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