Hi
I am in the process of updating an intended use statement for unassayed control material as some analytes are missing in the current statement. An alternative suggestion I received is to remove current specified analyte and go with a generic statement e.g this unassayed control can be used when testing clinical chemistry analytes" and not mentioning what the specific analytes are.
I think all analytes where the control is used should be specified. Any thoughts?
Best regards
Audrey