; and (B) mitigating measures are not able to be established and applied to prevent, mitigate, or detect the inaccurate result, or otherwise sufficiently mitigate the risk resulting from an undetected inaccurate result described in subparagraph (A), such that the test would be moderate-risk or low-risk. (10) Indications for use The term indications for use , with respect to an in vitro clinical test, means the following elements: (A) Substance or substances measured by the in vitro clinical test, such as an analyte, protein, or pathogen. (B) Test method. (C) Test purpose or purposes, as described in section 201(ss)(1). (D) Diseases or conditions for which the in vitro clinical test is intended for use, including intended patient populations. (E) Context of use, such as in a clinical laboratory, in a health care facility, prescription home use, over-the-counter use, or direct-to-consumer testing. (11) Instrument (A) In general The term instrument means an analytical or pre-analytical instrument. (B) Analytic instrument The term analytic instrument means an in vitro clinical test that is hardware intended by the developer to be used with one or more other in vitro clinical tests to generate a clinical test result, including software used to effectuate the functionality of the hardware. (C) Pre-analytical instrument The term pre-analytical instrument means an in vitro clinical test that is hardware intended by the developer solely to generate an output for use exclusively with one or more analytical instruments as defined in subparagraph (B) and which does not itself generate a clinical test result. Such term may include software used to effectuate the hardware’s functionality. (12) Instrument family The term instrument family means more than one instrument developed by the same developer for which the developer demonstrates and documents, with respect to all such instruments, that all— (A) have the same basic architecture, design, and performance characteristics