FDA product code JFT: Fluorometric, Cortisol
JFT is the FDA product code for fluorometric, cortisol. It is a Class II device, regulated under 21 CFR 862.1205 and reviewed by the Clinical Chemistry panel. FDA has cleared 20 510(k) submissions under JFT, 1 in the last five years, from 16 different applicants. The average 510(k) review took 125 days (median 112); 329 days on average over the last three years. FDA has posted 5 recalls for JFT devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fluorometric, Cortisol |
| Device class | Class II |
| Regulation | 21 CFR 862.1205 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JFT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 56 |
| 2025 | 1 | 329 |
Compare with all 510(k) review times · Search every JFT clearance
Top JFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 2 | 2025-07-17 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2019-11-25 |
| Ciba Corning Diagnostics Corp. | 2 | 1996-11-05 |
| Abbott Laboratories | 2 | 1985-11-25 |
| Seradyn, Inc. | 1 | 2006-09-22 |
11 more applicants have JFT clearances. See the full list in Caduvo.
Most recent JFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242505 | Roche Diagnostics | Elecsys Cortisol III | 2025-07-17 | 329 |
| K192788 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Cortisol (COR) | 2019-11-25 | 56 |
| K152227 | Roche Diagnostics | Elecsys Cortisol II, Cortisol II CalSet | 2016-04-27 | 264 |
| K142723 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Cortisol (COR) Assy | 2015-03-31 | 189 |
| K062204 | Seradyn, Inc. | ARCHITECT CORTISOL ASSAY | 2006-09-22 | 52 |
Recalls for JFT devices
5 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-03-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code JFT?
JFT is the FDA product code for fluorometric, cortisol. It is a Class II device, regulated under 21 CFR 862.1205 and reviewed by the Clinical Chemistry panel.
What device class is JFT?
Class II, regulation 21 CFR 862.1205. Typical premarket route: 510(k).
How long does a 510(k) take for product code JFT?
Across 20 cleared submissions the average was 125 days from receipt to decision (median 112).
Which companies have the most JFT clearances?
Roche Diagnostics (2); Siemens Healthcare Diagnostics, Inc. (2); Ciba Corning Diagnostics Corp. (2); Abbott Laboratories (2); Seradyn, Inc. (1).
Have JFT devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2023-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code JFT
- Run a recall and safety report across every JFT manufacturer
- Watch product code JFT 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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