Access Hybritech PSA
FDA premarket approval P850048/S060 · decided 2024-09-04
Approval details
- PMA number
- P850048
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Access Hybritech PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2024-03-28
- Decision date
- 2024-09-04
- Days to decision
- 160 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Migration of the Access Hybritech PSA to the DxI 9000 Access Immunoassay Analyzer.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
| Access anti-HBc IgM (K254059) | Beckman Coulter, Inc. | 2026-03-13 |
| Access anti-HBc Total (K253687) | Beckman Coulter, Inc. | 2026-02-19 |
| Access anti-HAV IgM (K251995) | Beckman Coulter, Inc. | 2026-01-27 |
| Access Rubella IgG (K250588) | Beckman Coulter, Inc. | 2025-11-17 |
| iQ200 Series (K252580) | Beckman Coulter, Inc. | 2025-09-10 |
| Access anti-HAV (K243846) | Beckman Coulter, Inc. | 2025-09-09 |
| MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804) | Beckman Coulter, Inc. | 2025-08-20 |