; and (ii) for which design and development (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, microbial culture, next generation sequencing, nephlometric or turbidimetric (non-immunoassay), singleplex or multiplex non-NGS nucleic acid analysis, slide-based technology, spectroscopy, and any other technology, as the Secretary determines appropriate. (19) Test The term test , unless otherwise provided, means an in vitro clinical test. (20) Valid scientific evidence The term valid scientific evidence — (A) means, with respect to an in vitro clinical test, evidence that— (i) has been generated and evaluated by persons qualified by training or experience to do so, using procedures generally accepted by other persons so qualified; and (ii) forms an appropriate basis for concluding by qualified experts whether the applicable standard has been met by the in vitro clinical test; and (B) may include evidence described in subparagraph (A) consisting of— (i) peer-reviewed literature; (ii) clinical guidelines; (iii) reports of significant human experience with an in vitro clinical test; (iv) bench studies; (v) case studies or histories; (vi) clinical data; (vii) consensus standards; (viii) reference standards; (ix) data registries; (x) postmarket data; (xi) real world data; (xii) clinical trials