FDA product code JZO: System, Test, Thyroid Autoantibody
JZO is the FDA product code for system, test, thyroid autoantibody. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel. FDA has cleared 92 510(k) submissions under JZO, 4 in the last five years, from 42 different applicants. The average 510(k) review took 104 days (median 76); 216 days on average over the last three years. FDA has posted 18 recalls for JZO devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Thyroid Autoantibody |
| Device class | Class II |
| Regulation | 21 CFR 866.5870 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JZO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 90 |
| 2023 | 2 | 537 |
| 2024 | 1 | 171 |
| 2025 | 1 | 262 |
Compare with all 510(k) review times · Search every JZO clearance
Top JZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Laboratory Products Co., Ltd. | 9 | 2001-05-30 |
| Roche Diagnostics Corp. | 5 | 2008-07-28 |
| Brahms Diagnostica, LLC | 5 | 2004-03-22 |
| Elias U.S.A., Inc. | 5 | 1993-01-14 |
| Pharmacia & Upjohn Co. | 4 | 2000-11-27 |
37 more applicants have JZO clearances. See the full list in Caduvo.
Most recent JZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250250 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-Thyroid Peroxidase II | 2025-10-17 | 262 |
| K240469 | Beckman Coulter, Inc. | Access TPO Antibody | 2024-08-09 | 171 |
| K213517 | Beckman Coulter, Inc. | Access Thyroglobulin Antibody II | 2023-09-26 | 692 |
| K222610 | Roche Diagnostics | Elecsys Anti-Tg | 2023-09-15 | 382 |
| K193313 | Roche Diagnostics | Elecsys Anti-TSHR | 2020-02-27 | 90 |
Recalls for JZO devices
18 product recalls in 11 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2025-11-21.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 4 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code JZO?
JZO is the FDA product code for system, test, thyroid autoantibody. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel.
What device class is JZO?
Class II, regulation 21 CFR 866.5870. Typical premarket route: 510(k).
How long does a 510(k) take for product code JZO?
Across 92 cleared submissions the average was 104 days from receipt to decision (median 76).
Which companies have the most JZO clearances?
American Laboratory Products Co., Ltd. (9); Roche Diagnostics Corp. (5); Brahms Diagnostica, LLC (5); Elias U.S.A., Inc. (5); Pharmacia & Upjohn Co. (4).
Have JZO devices been recalled?
Yes: 18 product recalls across 11 recall events; the most recent began 2025-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code JZO
- Run a recall and safety report across every JZO manufacturer
- Watch product code JZO 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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