How do General Purpose Reagents compare to ASRs?
A General Purpose Reagent (GPR) is “a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application.” 21 CFR 864.4010(a). Like ASRs, GPRs are not labeled for a specific clinical or diagnostic use. Because GPRs are not analyte-specific, they should have the potential to be combined with, or used in conjunction with more than one type of ASR by the laboratory or IVD manufacturer that develops the finished test. In contrast, as stated above, an ASR is a specific chemical component, probe, or antibody that by its design determines which individual chemical substance or ligand can be detected.
