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: VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator
• Generic Name: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
• Regulation Number: 866.3172
• Applicant: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr.; Rochester, NY 14626
• PMA Number: P030024
• Supplement Number: S024
• Date Received: 08/07/2017
• Decision Date: 09/01/2017
• Reclassified Date: 10/20/2025
• Product Code: LOM
• Advisory Committee: Microbiology
• 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  
Process improvements to increase to maximum batch size for manufacturing of anti-HBc coated wells from 2500 to 5000 plates.