FDA product code DHR: System, Test, Rheumatoid Factor
DHR is the FDA product code for system, test, rheumatoid factor. It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel. FDA has cleared 144 510(k) submissions under DHR, from 93 different applicants. The average 510(k) review took 80 days (median 52). FDA has posted 15 recalls for DHR devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Rheumatoid Factor |
| Device class | Class II |
| Regulation | 21 CFR 866.5775 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DHR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2018 | 1 | 81 |
| 2019 | 1 | 90 |
| 2020 | 1 | 236 |
Compare with all 510(k) review times · Search every DHR clearance
Top DHR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Behring Diagnostics, Inc. | 5 | 1994-10-20 |
| Inova Diagnostics, Inc. | 4 | 2019-04-17 |
| Beckman Instruments, Inc. | 4 | 1997-06-27 |
| Zeus Scientific, Inc. | 3 | 2004-02-27 |
| Roche Diagnostics Corp. | 3 | 2003-09-10 |
88 more applicants have DHR clearances. See the full list in Caduvo.
Most recent DHR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192727 | Kamiya Biomedical Company | K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) | 2020-05-20 | 236 |
| K190088 | Inova Diagnostics, Inc. | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | 2019-04-17 | 90 |
| K182747 | Phadia AB | EliA RF IgM Immunoassay | 2018-12-18 | 81 |
| K162263 | The Binding Site Group , Ltd. | Optilite Rheumatoid Factor Kit | 2017-05-03 | 265 |
| K160070 | The Binding Site Group , Ltd. | Rheumatoid Factor (RF) Kit for use on SPAPLUS | 2016-12-07 | 329 |
Recalls for DHR devices
15 product recalls in 15 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2019-11-06.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2019 | 4 |
Frequently asked questions
What is FDA product code DHR?
DHR is the FDA product code for system, test, rheumatoid factor. It is a Class II device, regulated under 21 CFR 866.5775 and reviewed by the Immunology panel.
What device class is DHR?
Class II, regulation 21 CFR 866.5775. Typical premarket route: 510(k).
How long does a 510(k) take for product code DHR?
Across 144 cleared submissions the average was 80 days from receipt to decision (median 52).
Which companies have the most DHR clearances?
Behring Diagnostics, Inc. (5); Inova Diagnostics, Inc. (4); Beckman Instruments, Inc. (4); Zeus Scientific, Inc. (3); Roche Diagnostics Corp. (3).
Have DHR devices been recalled?
Yes: 15 product recalls across 15 recall events; the most recent began 2019-11-06.
Next steps
- Run an FDA pathway report with predicate devices for product code DHR
- Run a recall and safety report across every DHR manufacturer
- Watch product code DHR 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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