ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
FDA 510(k) clearance K191578 · decided 2019-07-17
Clearance details
- K-number
- K191578
- Device name
- ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-14
- Decision date
- 2019-07-17
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- QFO
- Device class
- 2
- Regulation number
- 866.3935
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader (K200506) | Chembio Diagnostic Systems | 2020-06-03 |
| LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set (K192046) | DiaSorin, Inc. | 2019-10-28 |
| ZIKV Detect 2.0 IgM Capture ELISA (DEN180069) | InBios International, Inc. | 2019-05-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| IMMULITE 2000 AFP (P010007/S024) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM Anti-HBe2 (aHBe2) (P200017/S005) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S004) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036) | Siemens Healthcare Diagnostics, Inc. | 2025-08-14 |
| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |