iLine Microsystems microINR

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Hello!

Does anyone have any experience with iLine Microsystems microINR instrument? We have Coagucheks where I am, but some departments have difficulty getting enough blood from a capillary stick to get results. The microINR literature says it only takes 3uL for a sample, so I am interested to see what people might think of this new system.

Thank you,
Rachel

8 Replies

Hi Rachel, no I don't but I'll be watching for responses, too, since I was unaware of the product.

Since you are posting just as I noticed an unsolicited 'advertisement' from the company into my work email, I wasn't sure how my email address was acquired but I think I got my answer ;-).

It looks like the rep, Javier Alvarino, is a member on this site. Sneaky, sneaky.

Yes, I have just evaluated this meter and it is great!  It's like they took the best features of the other PT INR meters and combined it into one.
It correlated very well with the Stago in the lab.

I just checked the FDA website. It looked like the PT was waived, but the INR is mod complex. Not sure how that works, but I'd want to ask further questions before bringing it in.

Here is what is posted on their brochure:
Attachment.
image.png

Thanks Karen and Kathleen. Interesting. Since INR calculated and then interpreted, maybe that has something to do with the display of patient results? 

This is the clarification I received on the CLIA classification on the iLine PT/INR Meter:

The microINR family of coagulometers are all 3 CLIA-waived for PT/INR for monitoring are all 3 CLIA-waived for PT/INR for monitoring patients on Warfarin therapy.
The confusion may come from their first FDA clearance in 2019, which was initially classified as moderately complex. After additional submissions, the products were cleared as CLIA-waived (in 2020, 2023 and 2025).
 
So to clarify: both PT and INR reporting with the microINR system are currently CLIA-waived for this intended use.

Thanks Karen!

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Rachel Donner
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