How the USA wound up with the Dept of FUBAR and SNAFU in the most vital emergency medical treatment services is a travesty.Normally, no. It's reviewed by FDA and requires independent studies.
In this case, FDA has allowed 'self-verification' for these kits to be released. Basically with a 'buyer beware' sticker on them.
Tests that deliver false-positives? Compiled data and models from them that must be reanalyzed, of course. And, somehow, throughout this entire process, we are expected to believe that when procedures are in place, that they're reliable. Forgive me if I don't automatically have a sense of safety from these sources, by default.