Can a manufacturer or distributor promote specific ASRs and GPRs for use together in developing a test?
No. As explained above, ASRs are considered specific individual “building blocks” of LDTs and finished IVDs tests, while GPRs are not intended for any specific diagnostic application. 21 CFR 864.4010, 864.4020. A product that is promoted for use with an ASR is intended for a specific diagnostic use with that ASR and therefore would not meet the GPR definition of being for “general laboratory application.” Similarly, a product that is promoted for use with a specific GPR is intended for a particular intended use rather than as an ASR, which is a building block of LDTs. Therefore, a manufacturer who wishes to market its products as GPRs or ASRs should not promote or sell them together, including in finished or partial IVD test configurations. We recommend that manufacturers who wish to market multiple different products as ASRs, e.g. multiple ASR primer sets to amplify different mutation loci in a single gene, rather than as IVDs or IVD components, avoid marketing the ASRs in a manner th
