FDA product code DHA: System, Test, Human Chorionic Gonadotropin
DHA is the FDA product code for system, test, human chorionic gonadotropin. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel. FDA has cleared 72 510(k) submissions under DHA, 5 in the last five years, from 52 different applicants. The average 510(k) review took 117 days (median 76); 183 days on average over the last three years. FDA has posted 14 recalls for DHA devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Human Chorionic Gonadotropin |
| Device class | Class II |
| Regulation | 21 CFR 862.1155 |
| 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 DHA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 260 |
| 2019 | 1 | 30 |
| 2020 | 1 | 122 |
| 2021 | 3 | 324 |
| 2022 | 1 | 174 |
| 2023 | 3 | 163 |
| 2024 | 1 | 183 |
Compare with all 510(k) review times · Search every DHA clearance
Top DHA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 5 | 2023-06-05 |
| Germaine Laboratories, Inc. | 4 | 2002-01-22 |
| Dade Behring, Inc. | 3 | 2007-02-23 |
| Diagnostic Products Corp. | 3 | 2003-12-12 |
| Beckman Coulter, Inc. | 2 | 2022-12-27 |
47 more applicants have DHA clearances. See the full list in Caduvo.
Most recent DHA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233581 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | 2024-05-08 | 183 |
| K223690 | Shenzhen Yhlo Biotech Co., Ltd. | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | 2023-12-11 | 367 |
| K230937 | Abbott Laboratories | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | 2023-06-05 | 63 |
| K230790 | Abbott Laboratories | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series | 2023-05-19 | 58 |
| K221990 | Beckman Coulter, Inc. | Access Total ßhCG (5th IS) | 2022-12-27 | 174 |
Recalls for DHA devices
14 product recalls in 10 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2022-11-24.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2022 | 2 |
Frequently asked questions
What is FDA product code DHA?
DHA is the FDA product code for system, test, human chorionic gonadotropin. It is a Class II device, regulated under 21 CFR 862.1155 and reviewed by the Clinical Chemistry panel.
What device class is DHA?
Class II, regulation 21 CFR 862.1155. Typical premarket route: 510(k).
How long does a 510(k) take for product code DHA?
Across 72 cleared submissions the average was 117 days from receipt to decision (median 76).
Which companies have the most DHA clearances?
Abbott Laboratories (5); Germaine Laboratories, Inc. (4); Dade Behring, Inc. (3); Diagnostic Products Corp. (3); Beckman Coulter, Inc. (2).
Have DHA devices been recalled?
Yes: 14 product recalls across 10 recall events; the most recent began 2022-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DHA
- Run a recall and safety report across every DHA manufacturer
- Watch product code DHA 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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