JZO · System, Test, Thyroid Autoantibody
Immunology · 21 CFR 866.5870 · Class 2
Overview
| Product Code | JZO |
|---|---|
| Device Name | System, Test, Thyroid Autoantibody |
| Regulation | 21 CFR 866.5870 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 92)
Showing 20 most recent of 92 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | Oct 17, 2025 | SESE |
| K240469 | Access TPO Antibody | Beckman Coulter, Inc. | Aug 9, 2024 | SESE |
| K213517 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | Sep 26, 2023 | SESE |
| K222610 | Elecsys Anti-Tg | Roche Diagnostics | Sep 15, 2023 | SESE |
| K193313 | Elecsys Anti-TSHR | Roche Diagnostics | Feb 27, 2020 | SESE |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 | Phadia AB | Mar 25, 2016 | SESE |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | Mar 3, 2016 | SESE |
| K092229 | THYRETAIN TM TSI REPORTER BIOASSAY | Diagnostic Hybrids, Inc. | May 18, 2010 | SESE |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 | Theratest Laboratories, Inc. | Sep 3, 2009 | SESE |
| K083391 | THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY | Diagnostic Hybrids, Inc. | May 21, 2009 | SESE |
| K080092 | ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB | Roche Diagnostics Corp. | Jul 28, 2008 | SESE |
| K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | Kronus Market Development Associates, Inc. | May 22, 2008 | SESE |
| K061794 | FIDIS TM THYRO, MODEL MX002 | Biomedical Diagnostics (Bmd) SA | Nov 21, 2006 | SESE |
| K052407 | ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS | Fisher Diagnostics | Jul 18, 2006 | SESE |
| K061382 | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 | Beckman Coulter, Inc. | Jul 6, 2006 | SESE |
| K052308 | ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM | Fisher Diagnostics | May 10, 2006 | SESE |
| K053426 | ROCHE ELECSYS ANTI-TG | Roche Diagnostics Corp. | Feb 7, 2006 | SESE |
| K051890 | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO | Roche Diagnostics Corp. | Aug 4, 2005 | SESE |
| K033977 | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM | Zeus Scientific, Inc. | Mar 22, 2004 | SESE |
| K033454 | BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN | Brahms Diagnostica, LLC | Mar 22, 2004 | SESE |
Top Applicants
- American Laboratory Products Co., Ltd. — 9 clearances
- Roche Diagnostics Corp. — 5 clearances
- Elias U.S.A., Inc. — 5 clearances
- Brahms Diagnostica, LLC — 5 clearances
- Pharmacia & Upjohn Co. — 4 clearances
