JNL · Immunochemical, Thyroglobulin Autoantibody
Immunology · 21 CFR 866.5870 · Class 2
Overview
| Product Code | JNL |
|---|---|
| Device Name | Immunochemical, Thyroglobulin 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 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | Siemens Healthcare Diagnostics, Inc. | Dec 4, 2025 | SESE |
| K240996 | Access Thyroglobulin Antibody II | Beckman Coulter, Inc. | Jul 3, 2024 | SESE |
| K112933 | ACCESS THYROGLOBULIN ANITBODY | Beckman Coulter, Inc. | Dec 27, 2011 | SESE |
| K072661 | IMMUNOCAP THYRLOBULIN IMMUNOCAP | Phadia US, Inc. | Nov 20, 2007 | SESE |
| K062516 | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) | Beckman Coulter, Inc. | Oct 5, 2006 | SESE |
| K971834 | ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA | Monobind | Jul 3, 1997 | SESE |
| K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | Hycor Biomedical, Inc. | Nov 25, 1996 | SESE |
| K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | Hycor Biomedical, Inc. | Nov 25, 1996 | SESE |
| K954256 | ANTI-TPO | Biomerica, Inc. | Nov 27, 1995 | SESE |
| K951364 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | Nov 20, 1995 | SESE |
| K951362 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | Nov 20, 1995 | SESE |
| K952607 | AURAFLEX TPO-AB | Organon Teknika Corp. | Aug 25, 1995 | SESE |
| K951320 | AURAFLEX TG-AB AND TPO-AB | Organon Teknika Corp. | Aug 25, 1995 | SESE |
| K943580 | AUTOSTAT II ANTI-TPO | Cogent Diagnotics , Ltd. | Apr 17, 1995 | SESE |
| K941361 | MICROSOMAL EIA TEST KIT | Immunoprobe, Inc. | May 11, 1994 | SESE |
| K941358 | THYROGLOBULIN EIA TEST KIT | Immunoprobe, Inc. | May 11, 1994 | SESE |
| K930777 | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT | Nichols Institute | Apr 8, 1993 | SESE |
| K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL | Cogent Diagnotics , Ltd. | Sep 22, 1992 | SESE |
| K923370 | AUTOSTAT ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | Sep 22, 1992 | SESE |
| K921787 | SYNELISA TPO ANTIBODIES | Elias U.S.A., Inc. | Jul 28, 1992 | SESE |
Top Applicants
- Immunoprobe, Inc. — 4 clearances
- Cogent Diagnotics , Ltd. — 3 clearances
- Beckman Coulter, Inc. — 3 clearances
- Organon Teknika Corp. — 2 clearances
- Hycor Biomedical, Inc. — 2 clearances
