ADVIA Centaur Erythropoietin (EPO) assay
FDA 510(k) K183088 · Axis-Shield Diagnostics Limited
510(k) numberK183088
Submission
- Device name
- ADVIA Centaur Erythropoietin (EPO) assay
- Applicant
- Axis-Shield Diagnostics Limited
Dundee, GB - Received
- November 6, 2018
- Decision date
- August 2, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGT – Assay, Erythropoietin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7250
- Specialty
- Hematology
Other 510(k)s with product code GGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240182 | Access EPOGGT · Traditional | Beckman Coulter, Inc. | 04/22/2024SE |
| 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 |
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| K233541 | ARCHITECT Active-B12 (Holotranscobalamin)CDD · Traditional | 07/31/2024SE |
| K182012 | ADVIA Centaur Calcitonin (CALCT) assayJKR · Traditional | 12/21/2018SE |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCDD · Special | 10/27/2017SE |
| K153551 | ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality…NHX · Traditional | 08/04/2016SE |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…CDD · Traditional | 07/26/2016SE |
| K121946 | Axis-Shield ACVTIVE-B12CDD · Traditional | 03/22/2013SE |
| K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1CLCP · Traditional | 12/12/2012SE |
| K112790 | Axis-Shield 3-REAGENT Homocysteine Assay for SynchronLPS · Traditional | 05/07/2012SE |
Questions and answers
When was ADVIA Centaur Erythropoietin (EPO) assay cleared by the FDA?
ADVIA Centaur Erythropoietin (EPO) assay (K183088) received a 510(k) decision of Substantially Equivalent on August 2, 2019, 269 days after the submission was received.
What is the product code of K183088?
The FDA product code is GGT – Assay, Erythropoietin, a Class II (moderate risk) device regulated under 21 CFR 864.7250.