FDA issues "How to find and effectively use Predicate Devices" which states primary predicate is a must, Manufacturers may identify reference devices within their 510(k) to support scientific methodology or standard reference values

An update was posted by the FDA on "How to find and effectively use Predicate Devices". A previous posting indicated a single primary predicate is needed and that "the use of split predicates is inconsistent with the 510(k) regulatory standard".  It continued by stating "Manufacturers may identify “reference devices” within their 510(k) to support scientific methodology or standard reference values".