System, Test, Thyroglobulin
A Thyroglobulin Test System is an immunoassay-based in vitro diagnostic device used to measure thyroglobulin levels in serum, primarily used to monitor patients with differentiated thyroid cancer for recurrence or metastasis following thyroidectomy. It is FDA Class 2 requiring 510(k) clearance, with product code MSW under 21 CFR 866.6010 in the Immunology specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MSW
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242981 | Atellica IM Thyroglobulin (Tg) | Jun 20, 2025 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K240927 | Access Thyroglobulin | Jun 28, 2024 | Substantially Equivalent | Beckman Coulter, Inc. |
| K241423 | Access Thyroglobulin | Jun 07, 2024 | Substantially Equivalent | Beckman Coulter, Inc. |
| K221890 | Elecsys Tg II | Sep 30, 2023 | Substantially Equivalent | Roche Diagnostics |
| K220972 | Access Thyroglobulin | Sep 15, 2023 | Substantially Equivalent | Beckman Coulter, Inc. |
| K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS | May 02, 2003 | Substantially Equivalent | Beckman Coulter, Inc. |
| K021057 | BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS | Sep 17, 2002 | Substantially Equivalent | Brahms Diagnostica, LLC |
| K002888 | NICHOLS ADVANTAGE THYROGLOB | Oct 20, 2000 | Substantially Equivalent | Nichols Institute Diagnostics |
| K002905 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER | Oct 19, 2000 | Substantially Equivalent | Beckman Coulter, Inc. |
| K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | May 09, 2000 | Substantially Equivalent | Nichols Institute Diagnostics |
| K991720 | KRONUS OPTIQUANT THYROGLOBULIN KIT | Aug 09, 1999 | Substantially Equivalent | Unchanged |
| K982468 | IMMULITE 2000 THYROGLOBULIN MODEL L2KTY | Mar 12, 1999 | Substantially Equivalent | Diagnostic Products Corp. |
| K982466 | IMMULITE THYROGLOBULIN MODEL LKTY | Mar 12, 1999 | Substantially Equivalent | Diagnostic Products Corp. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.