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

11 Replies

Peggy Mann

Tue Mar 03, 2026 at 10:37AM

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 ;-).

Rachel Donner

Tue Mar 03, 2026 at 10:41AM

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

Karen Clark

Tue Mar 03, 2026 at 11:03AM

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.

Kathleen David

Tue Mar 03, 2026 at 5:38PM

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.

Karen Clark

Wed Mar 04, 2026 at 6:22AM

Here is what is posted on their brochure:

Peggy Mann

Wed Mar 04, 2026 at 8:30AM

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

Karen Clark

Wed Mar 04, 2026 at 9:15AM

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.

Peggy Mann

Wed Mar 04, 2026 at 10:53AM

Thanks Karen!

Tracy Learned

Mon Mar 09, 2026 at 2:03PM

Can it interface?

Tracy Learned

Wed Apr 15, 2026 at 9:57AM

Karen, may I ask how you purchased the meter and supplies? I just had a Teams meeting with them and would really like to try it. Looks like you have to just outright purchase one and take your chances.

Karen Clark

Thu Apr 16, 2026 at 8:52AM

I contacted the vendor and asked if we could evaluate their meter. They sent us a meter, strips and controls to use

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iLine Microsystems microINR