marketed in vitro clinical tests. (4) Special rule (A) Premarket review applicable Notwithstanding the exemptions from premarket review under section 587B set forth in subsections (b), (c), (d), (e), (f), (g), (h), (j), and (k) an in vitro clinical test (including any article for taking or deriving specimens) shall be subject to the requirements of section 587B if the Secretary determines, in accordance with subparagraph (B), that— (i) (I) there is insufficient valid scientific evidence to support the analytical validity or the clinical validity of such in vitro clinical test