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Patsy Gunn posted a reply on Re: NOVA StatStrip Validation

Tuesday, May 11, 2021 at 1:46 PM

Said: Nova came in and did the validation and training, but that was back in 2014. I do know that if you are CAP - there are now rules on validation being done by lab staff not just manufacturer - can't remember if applies to waived.&nb...

Miranda Scruggs posted a new Topic

Tuesday, May 11, 2021 at 1:22 PM

NOVA StatStrip Validation

Good afternoon everyone,

We are getting ready to switch over to NOVA StatStrips.
Does anyone have a copy of their validation plan/protocol for the implementation of these glucometers as new equipment that I could look at? How many patient samples did you use for method comparisons?

Also, if anyone has any training material, i.e. a PowerPoint, that would be greatly appreciated as well.

Apologies if this is a duplicate request, I know a lot of institutions are in...

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Daniel Larkin has joined the group.

Tuesday, May 11, 2021 at 12:56 PM

Daniel is Account Executive works at Abbott

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Max Mauch posted a reply on Re: CLIA waived breath alcohol test device - va...

Tuesday, May 11, 2021 at 8:22 AM

Said: 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.

Don Tran posted a reply on Re: CLIA waived breath alcohol test device - va...

Monday, May 10, 2021 at 5:17 PM

Said: 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. Th...