FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
PMA: P910007
·
Supplement: S068
·
Decision Feb 23, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
- Trade Name
- ARCHITECT Total PSA / Alinity i Total PSA (LN 6C06/07P92)
- PMA Number
- P910007
- Supplement Number
- S068
- Device Class
- FDA Class 3
- Product Code
- MTF
- Generic Name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 23, 2026
- Date Received
- January 26, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Update panel testing specifications.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MTF | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer | FDA class 3 | Unknown |