; (B) have the same indications for use and capabilities; (C) share the same measurement principles, detection methods, and reaction conditions, as applicable; and (D) produce the same or similar analytical results from samples of the same specimen type or types. (13) Laboratory operations The term laboratory operations — (A) means the conduct of a laboratory examination or other laboratory procedure on materials derived from the human body, including the conduct of an in vitro clinical test and associated activities, that is— (i) regulated under section 353 of the Public Health Service Act; and (ii) not related to the design, analytical validation, or clinical validation of an in vitro clinical test; and (B) includes— (i) performing pre-analytical and post-analytical processes for an in vitro clinical test; (ii) standard operating procedures and the conduct thereof; and (iii) preparing reagents or other test materials that do not meet the criteria for being an in vitro clinical test for clinical use. (14) Low-risk The term low-risk , with respect to an in vitro clinical test or category of in vitro clinical tests, means that an undetected inaccurate result from such in vitro clinical test, or such category of in vitro clinical tests, when used as intended— (A) would cause only minimal or immediately reversible harm, and would lead to only a remote risk of adverse patient impact or adverse public health impact; or (B) sufficient mitigating measures are able to be established and applied such that the in vitro clinical test meets the standard described in subparagraph (A). (15) Mitigating measures The term mitigating measures — (A) means controls, standards, and other requirements that the Secretary determines, based on evidence, are necessary— (i) for an in vitro clinical test, or a category of in vitro clinical tests, to meet the applicable standard; or (ii) to mitigate the risk of harm ensuing from an undetected inaccurate result or misinterpretation of a result