Does analyzer meet the definition of a “Family Member”?
• If NO, should submit a traditional 510k; one assay for each method to establish performance based on the analyzer specification • If YES, has new model passed acceptance criteria defined in your validation? • If NO, should submit special 510k that can be bundled with all reagents 510k cleared for use on the family of instruments • If YES, should internally document all data supporting validation of new analyzer to the family of instruments; no premarket submission or add-to-file to FDA needed. Should document all reagents and associated 510k numbers cleared for the family intended for use on the new analyzer.
