; and (ii) the clinical circumstances under which the in vitro clinical test is used, and the availability of other tests (such as confirmatory or adjunctive tests) or relevant material standards. (10) Indications for use The term indications for use means one or more in vitro clinical tests that have all of the following notification elements in common: (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)(A). (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 The term instrument means an in vitro clinical test that is hardware intended by the hardware’s developer to be used with one or more in vitro clinical tests to generate a clinical test result, including software used to effectuate the hardware’s functionality. (12) Instrument family The term instrument family means more than one instrument 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, such as tolerance limits and signal range; (B) have the same intended use or uses and function; (C) share the same measurement principles, detection methods, and reaction conditions; and (D) produce the same or similar analytical results from samples of the same specimen type or types. (13) Laboratory operations The term laboratory operations — (A) means the conduct of a laboratory examination or other laboratory procedure on materials derived from the human body, including the conduct of an in vitro clinical test and associated activities within or under the oversight of a laboratory and not related to the design of an in vitro clinical test