What is an FDA-approved PTH kit package insert?
The U.S. Food and Drug Administration (FDA), regulates PTH test kits. This means that all PTH test kits for clinical diagnostics in the USA must be approved by the FDA before they can be sold across state lines. Both the CAP assay and the Total Intact PTH assay that Scantibodies has discovered and developed have been approved by the FDA. Included in the FDAs review and approval are the PTH test kit instructions, also known as the package insert or labeling. A package insert for a PTH test kit cannot be changed by a manufacturer without the approval of the FDA. An integral part of these package inserts is the specimen requirement which includes whether or not the specimen may be stored (i.e., shipped) as whole blood prior to centrifugation.
