6 ms·

They also cleared the Pinnacle BioLabs assay. You can order a 2-pack or a 25-pack. https://www.pblabs.com/products/pinnacle-biolabs-covid-19-novel-coronavirus

They also cleared the Pinnacle BioLabs assay. You can order a 2-pack or a 25-pack. https://www.pblabs.com/products/pinnacle-biolabs-covid-19-novel-coronavirus-dual-igg-igm-rapid-test https://www.pblabs.com/products/pinnacle-biolabs-covid-19-no... Mine arrived in the mail this morning.

carlhu 7y ago
The kit looks very interesting. Unfortunately, it appears to me that the Pinnacle kit is not yet approved under the emergency fda authorization, yes? I'm using this web page for reference: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-med....
- joezydeco 7y ago
  The in-vitro EUA list on the FDA page only seems to cover PCR tests and not ELISA immunoassays (yet). Pinnacle's webpage earlier this week said they were shipping to the EU but waiting on the FDA EUA for shipments to the US. The tracking on my order was marked as held up at the factory. The EUA notice disappeared from their website on Wednesday, it shipped yesterday, and I got it this morning. It's reasonable to believe Pinnacle obeyed the rules and waited. My plans weren't to use the kit unless absolutely necessary, so I can wait for the documentation to update.
WoodenChair 7y ago
Are there any reviews? Any third party verification? How do I know that this is legitimate? These are sincere questions, I'm not just being difficult.
- scrollaway 7y ago
  Isn't FDA clearance the very definition of "third party verification"?
  - imperio59 7y ago
    Looks like they got a CE seal on Feb 20, per their website. That's something at least.
    - WoodenChair 7y ago
      Can we trust their website? Is it on another website somewhere?
  - WoodenChair 7y ago
    Is it on the FDA website somewhere?
aqme28 7y ago
Did you buy it for some sort of industry use, or as a regular consumer for personal testing?
- joezydeco 7y ago
  Personal use. I ordered it weeks ago purely as a hypothetical. If I was home sick with a flu, was it seasonal or was it nCov? This was before all the lockdowns started. I also bought a fingertip pulse oximeter for the same reason. I’m surprised those haven’t been hoarded...yet.
amvalo 7y ago
Seems to be a scam. If you look up their FDA registration number nothing shows up.
- joezydeco 7y ago
  I’ve used some of their other home testing kits before, like their colon cancer screening kit. Detects globin at 50 ng/mL and is board approved by gastroenterologists. The company isn’t a scam.
  - amvalo 7y ago
    Yeah, after digging into it more I saw that. Doesn't explain the missing FDA number though which is quite sketchy.
    - joezydeco 7y ago
      Their number is listed in the info brochure. https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19BrochureFront.pdf?v=1583766247 https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19Bro...
      - amvalo 7y ago
        Yeah, and it's not listed... in the actual FDA database.
        joezydeco 7y ago
        Found it in 3 clicks. Maybe it's been recently updated? https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=172941 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c... https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=651998&lpcd=QJR https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c...
        amvalo 7y ago
romski 7y ago
Link already removed :-(

carlhu 7y ago

The kit looks very interesting. Unfortunately, it appears to me that the Pinnacle kit is not yet approved under the emergency fda authorization, yes? I'm using this web page for reference: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-med....

joezydeco 7y ago
The in-vitro EUA list on the FDA page only seems to cover PCR tests and not ELISA immunoassays (yet). Pinnacle's webpage earlier this week said they were shipping to the EU but waiting on the FDA EUA for shipments to the US. The tracking on my order was marked as held up at the factory. The EUA notice disappeared from their website on Wednesday, it shipped yesterday, and I got it this morning. It's reasonable to believe Pinnacle obeyed the rules and waited. My plans weren't to use the kit unless absolutely necessary, so I can wait for the documentation to update.

WoodenChair 7y ago

Are there any reviews? Any third party verification? How do I know that this is legitimate? These are sincere questions, I'm not just being difficult.

scrollaway 7y ago
Isn't FDA clearance the very definition of "third party verification"?
- imperio59 7y ago
  Looks like they got a CE seal on Feb 20, per their website. That's something at least.
  - WoodenChair 7y ago
    Can we trust their website? Is it on another website somewhere?
- WoodenChair 7y ago
  Is it on the FDA website somewhere?

aqme28 7y ago

Did you buy it for some sort of industry use, or as a regular consumer for personal testing?

joezydeco 7y ago
Personal use. I ordered it weeks ago purely as a hypothetical. If I was home sick with a flu, was it seasonal or was it nCov? This was before all the lockdowns started. I also bought a fingertip pulse oximeter for the same reason. I’m surprised those haven’t been hoarded...yet.

amvalo 7y ago

Seems to be a scam. If you look up their FDA registration number nothing shows up.

joezydeco 7y ago
I’ve used some of their other home testing kits before, like their colon cancer screening kit. Detects globin at 50 ng/mL and is board approved by gastroenterologists. The company isn’t a scam.
- amvalo 7y ago
  Yeah, after digging into it more I saw that. Doesn't explain the missing FDA number though which is quite sketchy.
  - joezydeco 7y ago
    Their number is listed in the info brochure. https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19BrochureFront.pdf?v=1583766247 https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19Bro...
    - amvalo 7y ago
      Yeah, and it's not listed... in the actual FDA database.
      - joezydeco 7y ago
        Found it in 3 clicks. Maybe it's been recently updated? https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=172941 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c... https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=651998&lpcd=QJR https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c...
        amvalo 7y ago

romski 7y ago

Link already removed :-(