ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
FDA 510(k) clearance K102681 · decided 2011-05-04
Clearance details
- K-number
- K102681
- Device name
- ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-17
- Decision date
- 2011-05-04
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- LGD
- Device class
- 2
- Regulation number
- 866.3780
- 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 |
|---|---|---|
| Access Toxo IgG (K242022) | Beckman Coulter, Inc. | 2025-03-28 |
| Access Toxo IgM II (K242095) | Beckman Coulter, Inc. | 2024-10-11 |
| Alinity i Toxo IgM (K233932) | Abbott Laboratories | 2024-08-30 |
| ARCHITECT Toxo IgG (K210596) | Abbott Laboratories | 2022-05-19 |
| Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl (K162678) | Roche Diagnostics | 2017-06-23 |
| ADVIA Centaur Toxoplasma M (Toxo M) (K142826) | Siemens Healthcare Diagnostics, Inc. | 2015-12-22 |
| LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (K132234) | DiaSorin, Inc. | 2013-08-28 |
| LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II (K131441) | DiaSorin, Inc. | 2013-08-09 |
| VIDAS TOXO IGG AVIDITY (K101946) | bioMerieux, Inc. | 2011-05-18 |
| PLATELIA TOXO IGM KIT MODEL 26211 (K090847) | Bio-Rad Laboratories | 2009-07-01 |
| ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG (K073501) | Roche Diagnostics Corp. | 2008-06-09 |
| ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC (K080869) | Beckman Coulter, Inc. | 2008-05-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 PSA (P930027/S039) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| IMMULITE 2000 AFP (P010007/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| Atellica IM free PSA II (fPSAII) (P250026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| IMMULITE 2000 AFP (P010007/S025) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| IMMULITE 2000 PSA (P930027/S038) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| 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 |