Assay, Erythropoietin
FDA product code GGT · Class II (moderate risk) · 21 CFR 864.7250 · Hematology
20510(k) clearances
0PMA approvals
4recalls
Manufacturers
- R&D Systems, Inc. 3
- Amgen, Inc. 2
- Incstar Corp. 2
- Genzyme Corp. 2
- Nichols Institute 2
- Beckman Coulter Inc. 2
- Jcl Clinical Research Corp. 1
- Diagnostic Systems Laboratories, Inc. 1
- Ramco Laboratories, Inc. 1
- Nichols Institute Diagnostics 1
- Diagnostic Products Corp. 1
- Sangui Biotech, Inc. 1
- Axis-Shield Diagnostics, Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240182 | Access EPOGGT · Traditional | Beckman Coulter, Inc. | 04/22/2024SE |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assayGGT · Traditional | Axis-Shield Diagnostics Limited | 08/02/2019SE |
| K052223 | Access Epo AssayGGT · Abbreviated | Beckman Coulter, Inc. | 10/06/2006SE |
| K992799 | Sangui Biotech, Inc. Epo (Erythropoietin) Elisa KitGGT · Traditional | Sangui Biotech, Inc. | 06/07/2000SE |
| K983203 | Immulite Epo, Model #'S Lkepz & LKEP1GGT · Traditional | Diagnostic Products Corp. | 07/12/1999SE |
| K980737 | Advantage Chemiluminescence Erythropoietin ImmunoassayGGT · Traditional | Nichols Institute Diagnostics | 03/23/1999SE |
| K952559 | Erythropoietin Immunoassay KitGGT · Traditional | Nichols Institute | 05/29/1996SE |
| K954898 | Predicta Erythropoietin Kit (Modification)GGT · Traditional | Genzyme Corp. | 02/05/1996SE |
| K936016 | Quantikine IVD Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa)GGT · Traditional | R&D Systems, Inc. | 07/19/1994SE |
| K931756 | Quantikine(Tm) Erythropoietin Human Serum ControlsGGT · Traditional | R&D Systems, Inc. | 04/21/1994SE |
| K932650 | Erythropoietin Immunoassay KitGGT · Traditional | Nichols Institute | 03/11/1994SE |
| K931666 | Quantikine(Tm) Erythropoietin/Enz Link Immun AssayGGT · Traditional | R&D Systems, Inc. | 07/20/1993SE |
| K926390 | Predicta Erythropoietin KitGGT · Traditional | Genzyme Corp. | 06/25/1993SE |
| K910481 | Epo-RiaGGT · Traditional | Ramco Laboratories, Inc. | 11/29/1991SE |
| K903492 | DSL Erythropoietin (DSL # 1100)GGT · Traditional | Diagnostic Systems Laboratories, Inc. | 10/26/1990SE |
| K902639 | Epo-Trac(Tm) 125I Radioimmunoassay (Ria)GGT · Traditional | Incstar Corp. | 08/22/1990SE |
| K893393 | Epo-Trac by Radioimmunoassay (Ria)GGT · Traditional | Incstar Corp. | 11/21/1989SE |
| K894943 | Clinigen Erythropoietin Human Serum Controls 1,2,3GGT · Traditional | Amgen, Inc. | 10/10/1989SE |
| K882686 | Erythropoietin Enzyme ImmunoassayGGT · Traditional | Amgen, Inc. | 12/20/1988SE |
| K833957 | Erythropoietin EiaGGT · Traditional | Jcl Clinical Research Corp. | 03/23/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1249-2025 Class II | Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons)…Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to… | Beckman Coulter, Inc. | 02/03/2025Open, Classified |
| Z-1281-2024 Class II | ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World… | Siemens Healthcare Diagnostics, Inc. | 01/24/2024Open, Classified |
| Z-1280-2024 Class II | Atellica IM Erythropoietin (EPO) Assay (100 Test)Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World… | Siemens Healthcare Diagnostics, Inc. | 01/24/2024Open, Classified |
| Z-1390-2022 Class III | Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for…The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an… | R & D Systems, Inc. | 06/14/2022Completed |