|Trade Name||TPSA FLEX REAGENT|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes to the product instructions for use: 1) add a new section titled risk and safety to provide additional safety information about the preservatives present in some of the product reagents; 2) add information under the section titled precautions on the presence of sodium azide, along with hazard and disposal information; and 3) provide for reference only additional ufu changes being implemented concurrently with the safety information.