CG4 FDA approved
0 followers
0 Likes
Hi all,
The CG4's are on the FDA site as approved now!
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/results.cfm
18 Replies
Displaying items 1-15 of 18 in total
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| iSTAT in NICU -chem 8, CG4 | 5 | 0 | 259 | ||
| Rotem Sigma Validation Help | 1 | 0 | 104 | ||
| Hemochron Sig Elite use outside of manufacturer temperature range | 2 | 0 | 172 |
According to the literature provided by Abbott, this is just temporary during the COVID-19 epidemic.
yes, that was the initial use but now they have been fully approved by the FDA according to the FDA website. It is now there with the Chem8 cartridges.
Adonica,
I agree the CG4 was awaiting full approval.
The G3+ (blue) was approved for use during the COVID-19 pandemic only.
This is good news for us.
I just got word from Abbott that the CG4 has been fully approved just like the CHEM8, yay!
Just got my official FDA notice and looking at the new IFU for CG4. The reportable ranges have changed. The one that concerns me is for pH - new range is 7.0 - 7.7
We routinely see pHs <7, especially in labor and delivery and transport, cath lab, etc. We have never had any issues with the pH on any cartridge and have been able to verify the old reportable range 6.5 - 8.2 with no problem.
We were thinking about doing our own study so we could expand that lower end below 7. Does doing that make it a lab developed test so highly complex?
Unfortunately, yes, Danyel. According to the LDT definition, any modification of a cleared test system automatically makes it High complexity.
Marcia
I have another question that maybe someone can help me with :). Does the EUA get removed once the test/device is approved by the FDA? For the CG4 the EUA IFU and the final approval IFU are different. Can one stay with the EUA requirements?
IMHO, the EUA is an emergency use only circumstance ... an uncharacterized condition. Once the FDA characterises an assay, method, etc., the finalized IFU takes over and the guidance contained within must be followed. You can apply your own more stringent requirements ... QC every 8 hours instead of the regulatory daily, for example ... but you cannot continue to operate under the EUA guidance.
I would think that would make it a lab developed test. Thanks for catching that.
Nancy Epstein
Point of Care Coordinator
CHI Health Laboratories
402-398-6603![Attachment.]( "Call: 402-398-6603")
(office)
From: Danyel Olson via POCT Listserv (Groupsite) <users+1234833@poct.groupsite.com>
Sent: Thursday, April 16, 2020 2:07 PM
To: Epstein,Nancy K <Nancy.Epstein@alegent.org>
Subject: [POCT Listserv] Re: CG4 FDA approved
CAUTION: This email is not from a CHI source. Only click links or open attachments you know are safe. Please send as an attachment all spam/phishing and unusual emails to spam@catholichealth.net.
The information contained in this communication, including attachments, is confidential and private and intended only for the use of the addressees. Unauthorized use, disclosure, distribution or copying is strictly prohibited and may be unlawful. If you received
this communication in error, please inform us of the erroneous delivery by return e-mail message from your computer. Additionally, although all attachments have been scanned at the source for viruses, the recipient should check any attachments for the presence
of viruses before opening. CHI Health accepts no liability for any damage caused by any virus transmitted by this e-mail. Thank you for your cooperation.
Caution: This email is both proprietary and confidential, and not intended for transmission to (or receipt by) any unauthorized person(s). If you believe that you have received this email in error, do not read any attachments. Instead, kindly reply to the sender stating that you have received the message in error. Then destroy it and any attachments. Thank you.
Depending on the area and what analytes they need, all of our Istat locations have the ability to run either the CG4 or EG7 cartridge (never together though) and with the reportable ranges changing with the CG4, it looks like I will have to shorten the range for my EG7 also.
So for folks that have another blood gas cartridge in use in addition to the CG4, will you be changing your reportable range for all the other BG cartridges? or - Do you have your cartridges separated by locations so that one area wouldn't use the CG4 plus another BG cartridge?
We are only bringing it back at our ambulance site, and they don't transmit results to our LIS or EMRs. They're only using Chem8, BNP, and troponin, so we wouldn't have to change anything with other blood gas cartridges. I don't think i'd want to change the reportable range for the other cartridges; it would make them less useful.
In this instance I am glad we only run Lactic on the CG4 (blood gases on the CG8).
Good Luck!
PRMC CONFIDENTIALITY NOTICE: This message, including any attachments is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use,
disclosure or distribution is prohibited. If you are not the intended recipient, contact the sender by reply e-mail or telephone and destroy all copies of the original message.
I plan to turn off the gas portion of the CG4 and only use for lactate. We need to be able to result pHs <7 so we will just use the CG8 only for our gases now. I'll also have to turn on test select so they don't get everything off the CG8 every time they just want a gas. Always something...
What LIS or EMR are you using Kathleen? We have RALS and my ambulance and pediflite can transmit enroute.