Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens

[jerryz]

Hello, I have a question regarding two of our IVD products using human fecal stool specimen

The question is if the patient is provided a stand alone collection kit to collect their own fecal, then submit the specimen to test in the lab for diagnosis. Is the test considered professional use or lay-person use? The assay procedure is still being performed by lab professional personnel on the test cassette.

Much appreciated for any input.

 

[Ronen E]

Hello, I have a question regarding two of our IVD products using human fecal stool specimen

The question is if the patient is provided a stand alone collection kit to collect their own fecal, then submit the specimen to test in the lab for diagnosis. Is the test considered professional use or lay-person use? The assay procedure is still being performed by lab professional personnel on the test cassette.

Much appreciated for any input.

I'm guessing that the test kit is an IVD MD and the collection/container kit is an accessory to an IVD MD, so they each have separate designations.
What regulatory system are you looking at?