For diagnostic tests, the FDA requires that tests be produced in kit
form, and the kit
is what the FDA approves and regulates. An APA Assay kit
, in the Enzyme Linked ImmunoSorbent Assay (ELISA) microtiter plate format, has been developed for Autoimmune Technologies by Corgenix, Inc., and this kit is now being used in the U.S. clinical trials. The data obtained from these trials will then be submitted to the FDA in what is called a Pre-Market Approval, or PMA, application.”
Hope this helps.