Access anti-HBc IgM
FDA 510(k) clearance K254059 · decided 2026-03-13
Clearance details
- K-number
- K254059
- Device name
- Access anti-HBc IgM
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-17
- Decision date
- 2026-03-13
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- SEI
- Device class
- 2
- Regulation number
- 866.3173
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBc IgM (K260049) | Roche Diagnostics | 2026-04-07 |
| Elecsys Anti-HBc II (K260046) | Roche Diagnostics | 2026-04-07 |
| Access anti-HBc Total (K253687) | Beckman Coulter, Inc. | 2026-02-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |