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Jennifer Toncray posted a new Topic

Wednesday, Nov 23, 2022 at 8:54 AM

6-month comparison for waived?

We have a Coag Clinic that uses CoagSense, which is waived. They do fall under CAP currently. When I was reading over the checklists for the CAP standards, I am under the impression that you only need to do 6-month comparisons with the lab for non-waived testing. Is this correct?

Thank you all for being so helpful!

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Jean Roper posted a reply on Re: I-STAT Troponins

Wednesday, Nov 23, 2022 at 8:50 AM

Said: can you post a copy of the FDA letter?

Linda Hiebel posted a reply on Re: I-STAT Troponins

Wednesday, Nov 23, 2022 at 8:48 AM

Said: The letter states the cartridges will remain available. The FDA letter dated 11/8/22 warned they are not FDA cleared. I think we'll pull them until I see clearance on the FDA site.

Athena Gordan has joined the group.

Wednesday, Nov 23, 2022 at 8:39 AM

Athena

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Contessa Hall posted a reply on Re: I-STAT Troponins

Wednesday, Nov 23, 2022 at 8:35 AM

Said: Yes- okay to use it without FDA clearance or emergency use authorization.