FDA product code CEC: Radioimmunoassay, Free Thyroxine
CEC is the FDA product code for radioimmunoassay, free thyroxine. It is a Class II device, regulated under 21 CFR 862.1695 and reviewed by the Clinical Chemistry panel. FDA has cleared 92 510(k) submissions under CEC, 2 in the last five years, from 57 different applicants. The average 510(k) review took 104 days (median 71); 35 days on average over the last three years. FDA has posted 12 recalls for CEC devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Free Thyroxine |
| Device class | Class II |
| Regulation | 21 CFR 862.1695 |
| 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 CEC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 28 |
| 2018 | 2 | 80 |
| 2023 | 1 | 414 |
| 2024 | 1 | 35 |
Compare with all 510(k) review times · Search every CEC clearance
Top CEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 8 | 2017-10-27 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 8 | 1993-04-20 |
| Amersham Corp. | 5 | 1989-08-03 |
| Siemens Healthcare Diagnostics, Inc. | 4 | 2014-11-26 |
| Roche Diagnostics | 3 | 2023-04-07 |
52 more applicants have CEC clearances. See the full list in Caduvo.
Most recent CEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240273 | Beckman Coulter, Inc. | Access Free T4 | 2024-03-06 | 35 |
| K220456 | Roche Diagnostics | Elecsys FT4 IV | 2023-04-07 | 414 |
| K182423 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | MAGLUMI 2000 FT4 | 2018-10-04 | 28 |
| K181233 | Roche Diagnostics | Elecsys FT4 III | 2018-09-18 | 132 |
| K173122 | Abbott Laboratories | Abbott Architect Free T4 | 2017-10-27 | 28 |
Recalls for CEC devices
12 product recalls in 10 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code CEC?
CEC is the FDA product code for radioimmunoassay, free thyroxine. It is a Class II device, regulated under 21 CFR 862.1695 and reviewed by the Clinical Chemistry panel.
What device class is CEC?
Class II, regulation 21 CFR 862.1695. Typical premarket route: 510(k).
How long does a 510(k) take for product code CEC?
Across 92 cleared submissions the average was 104 days from receipt to decision (median 71).
Which companies have the most CEC clearances?
Abbott Laboratories (8); Bd Becton Dickinson Vacutainer Systems Preanalytic (8); Amersham Corp. (5); Siemens Healthcare Diagnostics, Inc. (4); Roche Diagnostics (3).
Have CEC devices been recalled?
Yes: 12 product recalls across 10 recall events; the most recent began 2019-04-30.
Next steps
- Run an FDA pathway report with predicate devices for product code CEC
- Run a recall and safety report across every CEC manufacturer
- Watch product code CEC 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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