; or (2) shift liability to health care practitioners or other users. 587V. Adulteration An in vitro clinical test shall be deemed to be adulterated: (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance. (2) If it has been developed, prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. (3) If its container or package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (4) If it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 721(a). (5) If its analytical or clinical validity, as applicable, or with respect to a specimen receptacle, its safety, falls below that which it purports or is represented to possess. (6) If it is required to be, declared to be, purports to be, or is represented as being, in conformity with any performance standard established or recognized under section 587R and is not in conformity with such standard. (7) If it is required to be in compliance with mitigating measures established under section 587E and is not in conformity with such mitigating measures. (8) If it fails to have in effect an approved premarket application under section 587B, unless such in vitro clinical test is in compliance with the requirements for— (A) offering without an approved premarket application under section 587D(b)(1); (B) an exemption from premarket approval under section 587C or 587G