DDC · Thyroglobulin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5870 · Class 2
Overview
| Product Code | DDC |
|---|---|
| Device Name | Thyroglobulin, Antigen, Antiserum, Control |
| 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | Quest Intl., Inc. | Jan 6, 2003 | SESE |
| K012208 | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 | Beckman Coulter, Inc. | Sep 7, 2001 | SESE |
| K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Feb 18, 2000 | SESE |
| K991610 | ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. | Zeus Scientific, Inc. | Jun 25, 1999 | SESE |
| K991179 | ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jun 17, 1999 | SESE |
| K971835 | ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA | Monobind | Jul 3, 1997 | SESE |
| K953066 | SERODIA ATG | Fujirebio America, Inc. | Aug 14, 1995 | SESE |
| K943625 | AUTOSTAT II ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | Dec 22, 1994 | SESE |
| K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | Biomerica, Inc. | Jul 18, 1994 | SESE |
| K930486 | QUANTA LITE(TM) THYROID T ELISA | Inova Diagnostics, Inc. | Mar 15, 1993 | SESE |
| K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST | Miles Laboratories, Inc. | Feb 2, 1987 | SESE |
| K780874 | THYMUNE-T | Burroughs Wellcome Co. | Jun 14, 1978 | SESE |
| K780873 | THYMUNE-M | Burroughs Wellcome Co. | Jun 14, 1978 | SESE |
Top Applicants
- Zeus Scientific, Inc. — 3 clearances
- Burroughs Wellcome Co. — 2 clearances
- Beckman Coulter, Inc. — 1 clearance
- Biomerica, Inc. — 1 clearance
- Cogent Diagnotics , Ltd. — 1 clearance
