ADVIA Centaur Anti-Thyroglobulin II (aTgII)
FDA 510(k) clearance K250816 · decided 2025-12-04
Clearance details
- K-number
- K250816
- Device name
- ADVIA Centaur Anti-Thyroglobulin II (aTgII)
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-18
- Decision date
- 2025-12-04
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- JNL
- Device class
- 2
- Regulation number
- 866.5870
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tarrytown, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Siemens Healthcare Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Access Thyroglobulin Antibody II (K240996) | Beckman Coulter, Inc. | 2024-07-03 |
| ACCESS THYROGLOBULIN ANITBODY (K112933) | Beckman Coulter, Inc. | 2011-12-27 |
| IMMUNOCAP THYRLOBULIN IMMUNOCAP (K072661) | Phadia US, Inc. | 2007-11-20 |
| ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) (K062516) | Beckman Coulter, Inc. | 2006-10-05 |
| ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (K971834) | Monobind | 1997-07-03 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (K962451) | Hycor Biomedical, Inc. | 1996-11-25 |
| HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (K962341) | Hycor Biomedical, Inc. | 1996-11-25 |
| ANTI-TPO (K954256) | Biomerica, Inc. | 1995-11-27 |
| THYROGLOBULIN EIA TEST KIT (K951362) | Immunoprobe, Inc. | 1995-11-20 |
| MICROSOMAL EIA TEST KIT (K951364) | Immunoprobe, Inc. | 1995-11-20 |
| AURAFLEX TG-AB AND TPO-AB (K951320) | Organon Teknika Corp. | 1995-08-25 |
| AURAFLEX TPO-AB (K952607) | Organon Teknika Corp. | 1995-08-25 |
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 |