FDA product code CEW: Radioimmunoassay, Parathyroid Hormone
CEW is the FDA product code for radioimmunoassay, parathyroid hormone. It is a Class II device, regulated under 21 CFR 862.1545 and reviewed by the Clinical Chemistry panel. FDA has cleared 86 510(k) submissions under CEW, 3 in the last five years, from 39 different applicants. The average 510(k) review took 95 days (median 72); 219 days on average over the last three years. FDA has posted 21 recalls for CEW devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Parathyroid Hormone |
| Device class | Class II |
| Regulation | 21 CFR 862.1545 |
| 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 CEW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 216 |
| 2019 | 1 | 165 |
| 2023 | 1 | 498 |
| 2024 | 2 | 219 |
Compare with all 510(k) review times · Search every CEW clearance
Top CEW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nichols Institute Diagnostics | 13 | 2004-06-08 |
| Scantibodies Laboratory, Inc. | 10 | 2006-03-01 |
| Diagnostic Products Corp. | 9 | 2002-08-21 |
| Diagnostic Systems Laboratories, Inc. | 6 | 2002-05-31 |
| Immuno Nuclear Corp. | 4 | 1983-05-09 |
34 more applicants have CEW clearances. See the full list in Caduvo.
Most recent CEW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231927 | Roche Diagnostics | Elecsys PTH , Elecsys PTH STAT | 2024-03-22 | 266 |
| K232791 | Beckman Coulter, Inc. | Access Intact PTH | 2024-03-01 | 172 |
| K221197 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | 2023-09-05 | 498 |
| K190702 | Fujirebio Diagnostics,Inc. | Lumipulse G whole PTH | 2019-08-30 | 165 |
| K163658 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | 2017-05-23 | 151 |
Recalls for CEW devices
21 product recalls in 19 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2025-09-22.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code CEW?
CEW is the FDA product code for radioimmunoassay, parathyroid hormone. It is a Class II device, regulated under 21 CFR 862.1545 and reviewed by the Clinical Chemistry panel.
What device class is CEW?
Class II, regulation 21 CFR 862.1545. Typical premarket route: 510(k).
How long does a 510(k) take for product code CEW?
Across 86 cleared submissions the average was 95 days from receipt to decision (median 72).
Which companies have the most CEW clearances?
Nichols Institute Diagnostics (13); Scantibodies Laboratory, Inc. (10); Diagnostic Products Corp. (9); Diagnostic Systems Laboratories, Inc. (6); Immuno Nuclear Corp. (4).
Have CEW devices been recalled?
Yes: 21 product recalls across 19 recall events; the most recent began 2025-09-22.
Next steps
- Run an FDA pathway report with predicate devices for product code CEW
- Run a recall and safety report across every CEW manufacturer
- Watch product code CEW 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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