- Device
- Elecsys free PSA Test System, Biotin remediation
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P000027
- Supplement
- S035
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2020-05-12
- Decision code
- APPR
- Date received
- 2019-11-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the update of the Elecsys free PSA immunoassay to improve the tolerance to biotin interference.