Access Thyroglobulin Antibody II
FDA 510(k) K213517 · Beckman Coulter, Inc.
510(k) numberK213517
Submission
- Device name
- Access Thyroglobulin Antibody II
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- November 3, 2021
- Decision date
- September 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JZO – System, Test, Thyroid Autoantibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5870
- Specialty
- Immunology
Other 510(k)s with product code JZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/17/2025SE |
| K240469 | Access TPO AntibodyJZO · Traditional | Beckman Coulter, Inc. | 08/09/2024SE |
| K222610 | Elecsys Anti-TgJZO · Traditional | Roche Diagnostics | 09/15/2023SE |
| K193313 | Elecsys Anti-TSHRJZO · Traditional | Roche Diagnostics | 02/27/2020SE |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…JZO · Traditional | Phadia AB | 03/25/2016SE |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/03/2016SE |
| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/18/2010SE |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | Theratest Laboratories, Inc. | 09/03/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/21/2009SE |
| K080092 | Elecsys Anti-Tshr Immunoassay, Elecsys Precicontrol ThyroabJZO · Traditional | Roche Diagnostics Corp. | 07/28/2008SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access Thyroglobulin Antibody II cleared by the FDA?
Access Thyroglobulin Antibody II (K213517) received a 510(k) decision of Substantially Equivalent on September 26, 2023, 692 days after the submission was received.
What is the product code of K213517?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.