MSW · System, Test, Thyroglobulin
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | MSW |
|---|---|
| Device Name | System, Test, Thyroglobulin |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification Rationale
Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Special Controls
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg) | Siemens Healthcare Diagnostics, Inc. | Jun 20, 2025 | SESE |
| K240927 | Access Thyroglobulin | Beckman Coulter, Inc. | Jun 28, 2024 | SESE |
| K241423 | Access Thyroglobulin | Beckman Coulter, Inc. | Jun 7, 2024 | SESE |
| K221890 | Elecsys Tg II | Roche Diagnostics | Sep 30, 2023 | SESE |
| K220972 | Access Thyroglobulin | Beckman Coulter, Inc. | Sep 15, 2023 | SESE |
| K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | May 2, 2003 | SESE |
| K021057 | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | Brahms Diagnostica, LLC | Sep 17, 2002 | SESE |
| K002888 | NICHOLS ADVANTAGE THYROGLOB | Nichols Institute Diagnostics | Oct 20, 2000 | SESE |
| K002905 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER | Beckman Coulter, Inc. | Oct 19, 2000 | SESE |
| K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | Nichols Institute Diagnostics | May 9, 2000 | SESE |
| K991720 | KRONUS OPTIQUANT THYROGLOBULIN KIT | Unchanged | Aug 9, 1999 | SESE |
| K982468 | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY | Diagnostic Products Corp. | Mar 12, 1999 | SESE |
| K982466 | IMMULITE THYROGLOBULIN MODEL LKTY | Diagnostic Products Corp. | Mar 12, 1999 | SESE |
Top Applicants
- Beckman Coulter, Inc. — 5 clearances
- Diagnostic Products Corp. — 2 clearances
- Nichols Institute Diagnostics — 2 clearances
- Brahms Diagnostica, LLC — 1 clearance
- Roche Diagnostics — 1 clearance
