iSTAT hs-TnI cartridge - pediatrics
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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 certainly do not want to have to go through a challenging method verification for this new cartridge (if it's even approved for peds??) and then transition yet again to core lab. I think that's just too challenging from a clinical care perspective.
Just looking for input. Thanks!
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 certainly do not want to have to go through a challenging method verification for this new cartridge (if it's even approved for peds??) and then transition yet again to core lab. I think that's just too challenging from a clinical care perspective.
Just looking for input. Thanks!
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We are also bringing it on board in all our main labs and on the iSTATs later this year.