What type of information about a particular ASR can an ASR manufacturer provide to a laboratory?
An ASR manufacturer may provide laboratories with information, including peer-reviewed and published/presented literature, that establishes characteristics of the ASR itself, such as information describing the single ligand or target the ASR detects. Such information may not, however, describe the use of an ASR in a specific test, including information regarding an ASR’s clinical utility and clinical performance as well as specific instructions-for-use and validation protocols. 21 CFR 809.30, 864.4020. When coupled with such information, the product would fall outside the definition of an ASR. See Section II, “What Meets the ASR Definition?”.
