FDA product code MSW: System, Test, Thyroglobulin
MSW is the FDA product code for system, test, thyroglobulin. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 13 510(k) submissions under MSW, 5 in the last five years, from 7 different applicants. The average 510(k) review took 178 days (median 153); 160 days on average over the last three years. FDA has posted 10 recalls for MSW devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Thyroglobulin |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MSW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 2 | 494 |
| 2024 | 2 | 52 |
| 2025 | 1 | 267 |
Compare with all 510(k) review times · Search every MSW clearance
Top MSW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 5 | 2024-06-28 |
| Nichols Institute Diagnostics | 2 | 2000-10-20 |
| Diagnostic Products Corp. | 2 | 1999-03-12 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 2025-06-20 |
| Roche Diagnostics | 1 | 2023-09-30 |
2 more applicants have MSW clearances. See the full list in Caduvo.
Most recent MSW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242981 | Siemens Healthcare Diagnostics, Inc. | Atellica IM Thyroglobulin (Tg) | 2025-06-20 | 267 |
| K240927 | Beckman Coulter, Inc. | Access Thyroglobulin | 2024-06-28 | 85 |
| K241423 | Beckman Coulter, Inc. | Access Thyroglobulin | 2024-06-07 | 18 |
| K221890 | Roche Diagnostics | Elecsys Tg II | 2023-09-30 | 458 |
| K220972 | Beckman Coulter, Inc. | Access Thyroglobulin | 2023-09-15 | 529 |
Recalls for MSW devices
10 product recalls in 8 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-07-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MSW?
MSW is the FDA product code for system, test, thyroglobulin. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is MSW?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSW?
Across 13 cleared submissions the average was 178 days from receipt to decision (median 153).
Which companies have the most MSW clearances?
Beckman Coulter, Inc. (5); Nichols Institute Diagnostics (2); Diagnostic Products Corp. (2); Siemens Healthcare Diagnostics, Inc. (1); Roche Diagnostics (1).
Have MSW devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2025-07-10.
Next steps
- Run an FDA pathway report with predicate devices for product code MSW
- Run a recall and safety report across every MSW manufacturer
- Watch product code MSW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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