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Danyel Olson posted a new Topic
Thursday, Jan 30, 2025 at 12:59 PM
iSTAT hs-TnI cartridge - pediatrics
Anyone else out there using iSTAT cTnI in a pediatric population? Got the notice today about the transition to the new hs-TnI. Here's the 510K K240984. I'm trying to get my hands on the IFU.
We currently do not have a main lab method in place - never have due to fairly low volumes. We want to transition all troponin I testing to the main lab but it got cut from the budget this year. But I certain...
We currently do not have a main lab method in place - never have due to fairly low volumes. We want to transition all troponin I testing to the main lab but it got cut from the budget this year. But I certain...
Amanda Casavant posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 12:49 PM
Said: HelloIf we are discussing the glucometer strips then as a waiver test under CAP & CLIA no validation is required. Not sure about TJC rules regarding waived testing. This is all I do before placing a new lot ...
Liz Reed posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 12:43 PM
Said: Thanks Jeremy. We were performing 10 QC tests per level, Linearity (duplicate), and 5 patient samples comparing them to the old lot and our main lab analyzer. Would you share what you do?
Jeremy MacDonald posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 12:39 PM
Said: I don't think there is a specific CAP reg that requires a LOT to LOT study or Cal/Ver a new LOT to be performed on the waived glucometer strips. However, given that it only takes a ...
Liz Reed posted a reply on Re: NOVA: New Lot Validation
Thursday, Jan 30, 2025 at 12:31 PM
Said: If anyone can direct me to the specific CAP or CLIA reg that addresses this, I would be most appreciative!
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