|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||QUANTIFERON TB GOLD IN TUBE|
|Classification Name||test, immunity, cell mediated, mycobacterium tuberculosis|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification of the quantiferon - tb gold to an in-tube collection system that consists of three blood collection tubes, nil, tb antigen, and mitogen. The device, as modified, will be marketed under the trade name quantiferon - tb gold in-tube and is indicated for use as an in vitro diagnostic test using a peptide cocktail simulating esat-6, cfp-10 and tb 7. 7(p4) proteins to stimulate cells in heparinized whole blood drawn directly into specialized blood collection tubes. Detection of interferon-y by enzyme-linked immunosorbent assay (elisa) is used to identify in vitro responses to these peptide antigens that are associated with mycobacterium tuberculosis infection.