I-STAT Troponins

We are CAP certified and I think with them it becomes a lab developed test if you continue to use them. They haven't weighted in yet but Abbott is talking with them. 

Upon notification yesterday from our Rep, we have ceased usage of the i-STAT Troponin cartridges at our freestanding ED and are sending the samples via STAT courier to the main lab (a city over) until we can get further guidance from CLIA, etc. In the mean-time, we are looking into validating the Troponin-I on our Triage instrument as an alternative. We currently only use the Triage for D-Dimer and BNP. So of course, we'll have to order the supplies and it's a holiday week. 

I'm fairly new to the POC world...what is the reasoning that I should pull this test from use in our ER? Is it  because lack of FDA clearance means the hospital won't get reimbursed/paid  (to whatever extent) for the tests? What is the "big picture" of this situation?

There is no need to panic here. Per my Abbott i-STAT rep, this letter is informational and doesn't require any action. This sentence in the letter is the key 
APOC has been in communication and continues to work closely with the FDA. The i-STAT cTnI cartridge will remain available in the U.S. for use as intended as a moderately complex test in a non-waived point of care setting. 
I'm sure we'll hear more in the coming week or so. For now, we can continue to use the Troponin cartridge as before.
Happy Thanksgiving, everyone! This could have been much worse! I'm counting this as a blessing.

I second what Kathleen David said. We are waiting on official FDA letter for guidance.

Has anyone found a post directly from the FDA yet? 
Anyone considering using as normal? We do not have another method in lab at this point. We could do all the testing in lab by techs and consider highly complex, etc. 

We will continue to use the Troponin cartridges as before until we hear anything more from FDA or CMS--or Abbott. I believe that Abbott has sent data to the FDA, so I'm not anticipating any problems in keeping the cartridges in use for mod complexity.