; (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; and (C) is not intended for testing donors, donations, and recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products. (2) High-risk test limitation or condition A high-risk test may be exempt under paragraph (1) from the requirements of this subchapter only if— (A) no component or part of such test, including any reagent, is introduced into interstate commerce under the exemption under subsection (b)(1) (relating to components or parts intended for further development), and any article for taking or deriving specimens from the human body used in conjunction with the test remains subject to the requirements of this subchapter; or (B) the test has been developed in accordance with the applicable test design and quality requirements under section 587J. (g) Humanitarian test exemption (1) In general An in vitro clinical test is exempt from premarket review under section 587B and may be lawfully marketed subject to the other applicable requirements of this Act, if— (A) such in vitro clinical test— (i) is intended for use for a disease or condition for which no more than 10,000 (or such other number determined by the Secretary) individuals would be subject to negative or positive diagnosis by such test in the United States per year; and (ii) is not intended to diagnose a contagious disease or condition that is highly likely to result in fatal or irreversibly debilitating outcome and for which prompt and accurate diagnosis offers the opportunity to mitigate a public health impact of the condition