; and (ii) all in vitro clinical tests and categories of in vitro clinical tests that are designated by the Secretary pursuant to subparagraph (C) as low-risk for purposes of this subsection. (C) Designation of tests and categories Without regard to subchapter II of chapter 5 of title 5, United States Code, the Secretary may designate, in addition to the tests and categories described in subparagraph (B)(i), additional in vitro clinical tests, and categories of in vitro clinical tests, as low-risk in vitro clinical tests for purposes of the exemption under this subsection. The Secretary may make such a designation on the Secretary’s own initiative or in response to a request by any person. In making such a designation for a test or category of tests, the Secretary shall consider— (i) whether the test, or category of tests, is low-risk (as defined in section 587); and (ii) such other factors as the Secretary determines to be relevant to the protection of the public health. (f) Manual tests (1) Exemption An in vitro clinical test is exempt from all requirements of this subchapter if the output of such in vitro clinical test is the result of direct, manual observation, without the use of automated instrumentation or software for intermediate or final interpretation, by a qualified laboratory professional, and such in vitro clinical test— (A) is designed, manufactured, and used within a single clinical laboratory for which a certificate is in effect under section 353 of the Public Health Service Act that meets the requirements under section 353 for performing high-complexity testing; (B) is not a high-risk test, or is a high-risk test that the Secretary has determined meets at least one condition in paragraph (2) and is otherwise appropriate for this exemption