FDA product code DGC: Ige, Antigen, Antiserum, Control
DGC is the FDA product code for ige, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 114 510(k) submissions under DGC, 3 in the last five years, from 56 different applicants. The average 510(k) review took 65 days (median 45); 403 days on average over the last three years. FDA has posted 3 recalls for DGC devices.
Classification
| Field | Value |
|---|---|
| Device name | Ige, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DGC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 29 |
| 2022 | 1 | 61 |
| 2023 | 1 | 421 |
| 2024 | 1 | 403 |
Compare with all 510(k) review times · Search every DGC clearance
Top DGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmacia, Inc. | 16 | 1997-04-23 |
| Ventrex Laboratories, Inc. | 12 | 1991-02-21 |
| Kallestad Laboratories, Inc. | 8 | 1985-07-10 |
| Diagnostic Products Corp. | 6 | 1989-09-28 |
| Hybritech, Inc. | 4 | 1986-11-03 |
51 more applicants have DGC clearances. See the full list in Caduvo.
Most recent DGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231151 | Kenota, Inc. | Kenota 1 Total IgE; Kenota 1 (instrument) | 2024-05-31 | 403 |
| K214068 | Biokit, S.A. | Quantia IgE | 2023-02-21 | 421 |
| K220178 | Beckman Coulter, Inc. | Total Immunoglobulin E (IgE) | 2022-03-23 | 61 |
| K193493 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Total IgE (tIgE) | 2020-01-15 | 29 |
| K161899 | Phadia AB | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls | 2016-07-28 | 17 |
Recalls for DGC devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code DGC?
DGC is the FDA product code for ige, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is DGC?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code DGC?
Across 114 cleared submissions the average was 65 days from receipt to decision (median 45).
Which companies have the most DGC clearances?
Pharmacia, Inc. (16); Ventrex Laboratories, Inc. (12); Kallestad Laboratories, Inc. (8); Diagnostic Products Corp. (6); Hybritech, Inc. (4).
Have DGC devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2018-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code DGC
- Run a recall and safety report across every DGC manufacturer
- Watch product code DGC 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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