ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA premarket approval P970038/S013 · decided 2011-02-07
Approval details
- PMA number
- P970038
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 2011-01-10
- Decision date
- 2011-02-07
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- APPROVAL TO ADD THE FOLLOWING NEW WARNING LABEL TO ALL ACCESS DXI SYSTEMS. ¿WARNING¿ ERRONEOUS RESULTS CAN OCCUR IF REAGENT PACKS ARE NOT LOADED PROPERLY. 1) NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM. 2) ALWAYS LOAD A REAGENT PACK BEFORE SCANNING THE BAR CODE (ACCESS/ACCESS 2 ONLY). FOR SPECIFIC INSTRUCTIONS, CONSULT THE SYSTEM DOCUMENTATION.
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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 |