FDA product code JNL: Immunochemical, Thyroglobulin Autoantibody
JNL is the FDA product code for immunochemical, thyroglobulin autoantibody. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel. FDA has cleared 22 510(k) submissions under JNL, 2 in the last five years, from 12 different applicants. The average 510(k) review took 111 days (median 83); 172 days on average over the last three years. FDA has posted 4 recalls for JNL devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Immunochemical, Thyroglobulin 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 JNL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 83 |
| 2025 | 1 | 261 |
Compare with all 510(k) review times · Search every JNL clearance
Top JNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immunoprobe, Inc. | 4 | 1995-11-20 |
| Beckman Coulter, Inc. | 3 | 2024-07-03 |
| Cogent Diagnotics , Ltd. | 3 | 1995-04-17 |
| Hycor Biomedical, Inc. | 2 | 1996-11-25 |
| Organon Teknika Corp. | 2 | 1995-08-25 |
7 more applicants have JNL clearances. See the full list in Caduvo.
Most recent JNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250816 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | 2025-12-04 | 261 |
| K240996 | Beckman Coulter, Inc. | Access Thyroglobulin Antibody II | 2024-07-03 | 83 |
| K112933 | Beckman Coulter, Inc. | ACCESS THYROGLOBULIN ANITBODY | 2011-12-27 | 85 |
| K072661 | Phadia US, Inc. | IMMUNOCAP THYRLOBULIN IMMUNOCAP | 2007-11-20 | 60 |
| K062516 | Beckman Coulter, Inc. | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) | 2006-10-05 | 38 |
Recalls for JNL devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-09-05.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code JNL?
JNL is the FDA product code for immunochemical, thyroglobulin autoantibody. It is a Class II device, regulated under 21 CFR 866.5870 and reviewed by the Immunology panel.
What device class is JNL?
Class II, regulation 21 CFR 866.5870. Typical premarket route: 510(k).
How long does a 510(k) take for product code JNL?
Across 22 cleared submissions the average was 111 days from receipt to decision (median 83).
Which companies have the most JNL clearances?
Immunoprobe, Inc. (4); Beckman Coulter, Inc. (3); Cogent Diagnotics , Ltd. (3); Hycor Biomedical, Inc. (2); Organon Teknika Corp. (2).
Have JNL devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2024-09-05.
Next steps
- Run an FDA pathway report with predicate devices for product code JNL
- Run a recall and safety report across every JNL manufacturer
- Watch product code JNL 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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