; (iii) the labeling and advertising for the in vitro clinical test are not false or misleading; (iv) the in vitro clinical test is not likely to cause or contribute to serious adverse health consequences; and (v) the in vitro clinical test is not intended for screening. (C) Exception for certain tests An in vitro clinical test intended to inform the use of a specific individual or specific type of biological product, drug, or device shall be eligible for an exemption from premarket review under this subsection only if, the developer submits a request under section 587F(e) for informal feedback and the Secretary determines that such in vitro clinical test is eligible for an exemption from premarket review under this subsection. (4) Custom tests and low-volume tests An in vitro clinical test is exempt from premarket review under section 587B, quality requirements under section 587K, and listing requirements under section 587J, and may be lawfully offered subject to the other applicable requirements of this Act, if— (A) such in vitro clinical test— (i) is a test protocol performed for not more than 5 patients per year (or such other higher number determined by the Secretary), in a laboratory certified by the Secretary under section 353 of the Public Health Service Act that— (I) meets the requirements to perform tests of high-complexity in which the test protocol was developed; or (II) meets the requirements to perform tests of high-complexity within the same corporate organization and having common ownership by the same parent corporation as the laboratory in which such test protocol was developed