CHEM8 and CG4 Blue cartridge

Does anyone have the CG4 clearance letter from Abbott to share?

Kelley, where did you get that information? I haven't heard anything.

CHEM8+ Clearance Customer Letter_ (002).pdf

Has anyone heard anything else about the rumor on the white CG4? I'm being told by my rep that this was just a discussion item and there's no confirmation that it will actually be available.

I'm holding off on my purchase of some alternate analyzers until I hear what's going on in the next couple days.

Has anyone taken a close look at the CHEM8 IFU recently released? It seems there are many discrepancies in it when compared to the previous published literature from Abbot (and when compared to the other IFUs).

Most notable is the 'limitations/interference' section - the CHEM8 lists out many substances as having "no" interference to specific analytes, when they previously claimed to, at the same concentrations..

HI ,

I just got a phone call from my Abbott rep, apparently CG4+ has been fad cleared for emergency cases due to covid-19. I am supposed to get the official letter in 48 hours. anyone else heard from Abbott about this ?

Yes, I got a call from my rep as well. She anticipates that, by the time the crisis is over, the CG4+ will be FDA approved. Apparently the G3+ is also covered by this EUA, although they won't be making those after May 1.

I'm still waiting to see the letter.  Is it for COVID patients only??

The Chem8 has already been FDA approved for use as mod complexity, no capillary sampling. The CG4+ is only EUA approved. I would imagine it would be used as mod complexity as well. Our rep told us that Abbott is hopeful that, by June, the CG4+ would be FDA approved. I don't believe they are drilling down to see that it's only used on Covid patients; that would be an inordinate amount of busy-work that would serve no purpose.

I finally got the letter for the CG4.  The IFU has removed the capillary as we all guessed but it does include the non heparin (plain) syringe so I am happy!  That was our biggest issue because we didn't use heparinized syringes for our Istat and it has been difficult finding a 1cc luer lock hep syringe.  Atleast for the time being we can reinstate the CG4 if they want it.

We'll be doing the same thing Adonica - I was this close to ordering ABL90s but things have changed so drastically that we just do not have the resources to move forward with that. We never used capillary so it's an easy choice to just go back to the CG4s. I would think the real clearance would come soon.

Have any of you looked/found the official Letter of Authorization on the FDA website for CG4s?  In their letter it states "Abbott Point of Care will provide additional information regarding the disposition of these tests at the termination of the COVID-19 pandemic."

According to CMS website an EUA allows use of an unapproved medical product during an emergency to diagnose, treat, or prevent a serious or life-threatening disease or condition caused by a CBRN agent if certain criteria are met. So it does not sound like it is cleared for all patients; only those for COVID-19. 

I don't know how anyone could possibly keep track of which patients the cartridges could be used on. We will move ahead in some of our sites to use these for whatever patients the providers order them on. Perhaps CMS, CAP, TJC, or COLA would come by afterwards asking to see our records and verifying that we only used them on Covid patients, but I just don't see that happening. I don't interpret as it can only be used on Covid patients, I interpret it as being able to use it during the Covid crisis on whatever patients need testing. I could be wrong, but that's how we're seeing it.