Clinical ADA Method: Universal vs In Study Cut Point?

With blockbuster drug for treatment of a variety disease indications, the pre-study validated ADA method will be applied to different indications. The validity of the pre-determined cut point during pre-study validation will be verified during study bioanalysis with false positive rate calculation. However if a FPR is below the previously validated range, will an in-study cut point automatically be triggered? Or it is the drug itself low immunogenic? The discussion will be focused on when and how to apply an in-study cut point during clinical development