Can the manufacturer include instructions with an ASR?
ASR manufacturers should not provide instructions for developing or performing an assay with an ASR. As explained above, FDA does not view reagents that are sold with instructions for developing or performing a test as ASRs because ASRs are intended to be building blocks for tests and are intended to be used to develop a test for which the developer must establish instructions for use and performance claims. 21 CFR 809.10(e)(1)(x), 809.30(d)(4). Instructions for use of an ASR in a particular test would constitute a claim that, when used as directed, the ASR will perform to detect a particular chemical substance or ligand. On the other hand, instructions for proper storage and handling of an ASR must be provided. 21 CFR 809.10(e)(1)(vi). In addition, scientific information may be included on chemical/molecular composition, concentration or mass, nucleic acid sequence, binding affinity, cross-reactivities, known mutations associated with the sequence, and interaction with substances of k
