Which statement is true regarding an adulterated device?

The correct understanding of an adulterated device emphasizes that deviations from standard strength or quality do not classify a device as adulterated if those deviations are clearly stated and labeled. This means that as long as the device accurately reflects its composition or strength on the label, it does not fall under the definition of adulteration, which typically pertains to hidden deficiencies or misleading information about quality. Transparency in labeling is key in determining whether a device meets the necessary standards.

In contrast, the other statements suggest different criteria for what constitutes adulteration. Devices do not need to meet all quality standards without exceptions, as clear labeling can allow for some deviations. Hence, asserting that all quality standards must be met without exception is overly stringent. The statement about the requirement to report to a health agency implies that acknowledgment or reporting is a factor in determining adulteration, which is not the case. The definition focuses on the condition and labeling of the device rather than external reporting requirements. Lastly, the notion that it must not differ from advertised quality implies that any variation leads to adulteration, but this does not hold true if those variations are explicitly disclosed. This understanding highlights the importance of accurate labeling rather than strict adherence to every single quality standard without exception.