PMA P060005S026

Device: IMMULITE Systems Free PSA
Applicant: Siemens Medical Solutions Diagnostics Limited
PMA number: P060005
Supplement: S026
Product code: MTG
Decision date: 2026-08-20
Classification: Immunology
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Approval order statement: Approval of the change to the bead drying process used in the manufacture of bead components for the IMMULITE 2000 AFP, Free PSA, and PSA assays.

Current openFDA PMA Record#

Device: IMMULITE Systems Free PSA
Applicant: Siemens Medical Solutions Diagnostics Limited
PMA number: P060005
Supplement: S026
Product code: MTG
Generic name: Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Decision date: 2026-08-20
Decision code: OK30
Date received: 2026-07-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of the change to the bead drying process used in the manufacture of bead components for the IMMULITE 2000 AFP, Free PSA, and PSA assays.