FDA product code DHX: System, Test, Carcinoembryonic Antigen
DHX is the FDA product code for system, test, carcinoembryonic antigen. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 28 510(k) submissions under DHX, 2 in the last five years, from 24 different applicants. The average 510(k) review took 119 days (median 94). 8 PMA applications cite this product code. FDA has posted 9 recalls for DHX devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Carcinoembryonic Antigen |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DHX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 76 |
| 2023 | 2 | 178 |
Compare with all 510(k) review times · Search every DHX clearance
Top DHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 3 | 2023-09-22 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 2004-06-17 |
| Tosoh Medics, Inc. | 2 | 2002-12-18 |
| Ortho Clinical Diagnostics | 1 | 2023-08-23 |
| Siemens Healthcare Disgnostics, Inc. | 1 | 2020-04-13 |
19 more applicants have DHX clearances. See the full list in Caduvo.
Most recent DHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223921 | Beckman Coulter, Inc. | Access CEA | 2023-09-22 | 267 |
| K231517 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products CEA Reagent Pack | 2023-08-23 | 90 |
| K200215 | Siemens Healthcare Disgnostics, Inc. | ADVIA Centaur CEA Assay | 2020-04-13 | 76 |
| K081615 | Olympus America, Inc. | OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN | 2009-03-18 | 282 |
| K080194 | bioMerieux, Inc. | VIDAS CEA (S) ASSAY | 2008-10-09 | 258 |
Recalls for DHX devices
9 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-05.
| Year | Recalls |
|---|---|
| 2018 | 3 |
Frequently asked questions
What is FDA product code DHX?
DHX is the FDA product code for system, test, carcinoembryonic antigen. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is DHX?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code DHX?
Across 28 cleared submissions the average was 119 days from receipt to decision (median 94).
Which companies have the most DHX clearances?
Beckman Coulter, Inc. (3); Ortho-Clinical Diagnostics, Inc. (2); Tosoh Medics, Inc. (2); Ortho Clinical Diagnostics (1); Siemens Healthcare Disgnostics, Inc. (1).
Have DHX devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2018-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code DHX
- Run a recall and safety report across every DHX manufacturer
- Watch product code DHX 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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