ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA premarket approval P850048/S042 · decided 2016-08-26
Approval details
- PMA number
- P850048
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2016-07-28
- Decision date
- 2016-08-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Manufacturing process change to use PSA reference calibrators instead of commercial calibrators to establish a valid calibration curve during the in-process qualification of the coated PSA paramagnetic particles.
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510(k) clearances by this applicant
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|---|---|---|
| Access BNP II (K252169) | Beckman Coulter, Inc. | 2026-03-24 |
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| 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 |
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