ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
FDA 510(k) clearance K112624 · decided 2012-09-10
Clearance details
- K-number
- K112624
- Device name
- ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-09-08
- Decision date
- 2012-09-10
- Days to decision
- 368 days
- Clearance type
- Traditional
- Product code
- OIU
- Device class
- 2
- Regulation number
- 866.6010
- 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 HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (K151378) | Fujirebio Diagnostics,Inc. | 2015-11-24 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL (K103676) | Fujirebio Diagnostics,Inc. | 2011-07-19 |
| ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, (K093957) | Fujirebio Diagnostics,Inc. | 2010-03-18 |
| HE4 EIA, MODEL: 404-10 US (K072939) | Fujirebio Diagnostics,Inc. | 2008-06-09 |
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 |