|Trade Name||ARCHITECT TOTAL PSA|
|Classification Name||total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer|
|Generic Name||immunochemistry analyzer|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the quality control testing used to assess the suitability of in-process architect total psa bulk secondary calibrator materials and architect free psa bulk product calibrator/ control materials.