; or (ii) to mitigate the risk of harm ensuing from an inaccurate result or misinterpretation of any result; and (B) includes, as appropriate, applicable requirements regarding labeling, performance standards, performance testing, submission of clinical data, advertising, website posting of information, clinical studies, postmarket surveillance, user comprehension studies, training, and conformance to standards. (16) Specimen receptacle The term specimen receptacle means an in vitro clinical test specifically intended for the holding, storing, or transporting of specimens derived from the human body or for in vitro examination for purposes described in clause (i) or (ii) of section 201(ss)(1)(A). (17) Technology The term technology — (A) means a developer’s grouping of in vitro clinical tests that do not significantly differ in control mechanisms, energy sources, or operating principals and for which design, development, and manufacturing, including analytical and clinical validation as applicable, of the tests would be addressed in a similar manner or through similar procedures; and (B) may include clot detection, colorimetric (non-immunoassay), electrochemical (non-immunoassay), enzymatic (non-immunoassay), flow cytometry, fluorometry (non-immunoassay), immunoassay, mass spectrometry or chromatography (such as HPLC), microbial culture, next generation sequencing (also known as NGS ), nephlometric or turbidimetric (non-immunoassay), singleplex or multiplex non-NGS nucleic acid analysis, single-based technology, spectroscopy, and any other technology, as the Secretary determines appropriate. (18) Test The term test , unless otherwise provided, means an in vitro clinical test. (19) Valid scientific evidence The term valid scientific evidence — (A) means, with respect to an in vitro clinical test, evidence— (i) that has been generated and evaluated by persons qualified by training or experience to do so, using procedures generally accepted by other persons so qualified