CLIA waived breath alcohol test device - validation needed?

Hello, 
We asked about this during our 2018 JC inspection and they told me that breath isn't a measurable body substance so it doesn't follow CLIA rules for validation. 

I asked after I was cited on pH paper used for eye splashes. I was told this case was a measurable specimen, tears, so had to do a validation. 

I also have POC Breathalyzer that is done entirely by the ED with no input from POC. I've never had it come up in an inspection. 

I do not think CLIA consider a breath test a test because there is no patient specimens or samples involved.  If you cannot find it in the FDA's database to determine its test complexity, most likely it is not a CLIA test.  Therefore, I don't think a validation/verification is necessary.  As always, please consult with the manufacturer and CAP for confirmation.

BAT is does not fall under Laboratory regulations (no patient sample collected).  If you wanted to run a validation, you would need to follow the manufacturers instruction.