Elecsys Phospho-Tau (181P) Plasma
FDA 510(k) clearance K252163 · decided 2025-10-08
Clearance details
- K-number
- K252163
- Device name
- Elecsys Phospho-Tau (181P) Plasma
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2025-07-10
- Decision date
- 2025-10-08
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- SET
- Device class
- 2
- Regulation number
- 866.5840
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Indianapolis, IN, 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 |
|---|---|---|
| Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706) | Fujirebio Diagnostics,Inc. | 2025-05-16 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |