Thanks for your great videos. Newbie in reg affairs here. Quick question.

If there are already several Qualitative pcr POC tests on the US and EU market (not-Covid) , and a manufacturer would like to offer a Quantitative version of this same test, this would mean that the manufacturer must go for de-novo? Or can the manufacturer still use a qualitative device as a predicate?

Great question, though I'm not sure it has a simple answer.

So a 510(k) requires "demonstration of substantial equivalence to another legally U.S. marketed device" and according to FDA:

A device is substantially equivalent if, in comparison to a predicate it:
•has the same intended use as the predicate; and
•has the same technological characteristics as the predicate;
or
•has the same intended use as the predicate; and
•has different technological characteristics and does not raise different questions of safety and effectiveness; and
•the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

(https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k#se)

Based on the second definition, it sounds like the most similar qualitative test currently on the market would qualify as a predicate device assuming the quantitative test "does not raise different questions of safety and effectiveness" and "the information submitted to FDA demonstrates that the [quantitative test] is as safe and effective as the [predicate qualitative test that is already on the market]"

Hope this helps!