Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Access Hybritech PSA Assay
• Generic Name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
• Applicant: Beckman Coulter, Inc.; 250 S. Kraemer Blvd. M/S; W-110; Brea, CA 92822
• PMA Number: P850048
• Supplement Number: S048
• Date Received: 09/28/2017
• Decision Date: 10/24/2017
• Product Code: MTF
• Advisory Committee: Immunology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Addition of a supplier manufacturing site for the production of the UniCel DxI reaction vessels.