FDA product code GGT: Assay, Erythropoietin
GGT is the FDA product code for assay, erythropoietin. It is a Class II device, regulated under 21 CFR 864.7250 and reviewed by the Hematology panel. FDA has cleared 20 510(k) submissions under GGT, 1 in the last five years, from 13 different applicants. The average 510(k) review took 222 days (median 210); 90 days on average over the last three years. FDA has posted 5 recalls for GGT devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Erythropoietin |
| Device class | Class II |
| Regulation | 21 CFR 864.7250 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GGT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 269 |
| 2024 | 1 | 90 |
Top GGT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R&D Systems, Inc. | 3 | 1994-07-19 |
| Beckman Coulter, Inc. | 2 | 2024-04-22 |
| Nichols Institute | 2 | 1996-05-29 |
| Genzyme Corp. | 2 | 1996-02-05 |
| Incstar Corp. | 2 | 1990-08-22 |
8 more applicants have GGT clearances. See the full list in Caduvo.
Most recent GGT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240182 | Beckman Coulter, Inc. | Access EPO | 2024-04-22 | 90 |
| K183088 | Axis-Shield Diagnostics Limited | ADVIA Centaur Erythropoietin (EPO) assay | 2019-08-02 | 269 |
| K052223 | Beckman Coulter, Inc. | ACCESS EPO ASSAY | 2006-10-06 | 417 |
| K992799 | Sangui Biotech, Inc. | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | 2000-06-07 | 293 |
| K983203 | Diagnostic Products Corp. | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 | 1999-07-12 | 301 |
Recalls for GGT devices
5 product recalls in 4 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-02-03.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code GGT?
GGT is the FDA product code for assay, erythropoietin. It is a Class II device, regulated under 21 CFR 864.7250 and reviewed by the Hematology panel.
What device class is GGT?
Class II, regulation 21 CFR 864.7250. Typical premarket route: 510(k).
How long does a 510(k) take for product code GGT?
Across 20 cleared submissions the average was 222 days from receipt to decision (median 210).
Which companies have the most GGT clearances?
R&D Systems, Inc. (3); Beckman Coulter, Inc. (2); Nichols Institute (2); Genzyme Corp. (2); Incstar Corp. (2).
Have GGT devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2025-02-03.
Next steps
- Run an FDA pathway report with predicate devices for product code GGT
- Run a recall and safety report across every GGT manufacturer
- Watch product code GGT 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.