GGT · Assay, Erythropoietin
Hematology · 21 CFR 864.7250 · Class 2
Overview
| Product Code | GGT |
|---|---|
| Device Name | Assay, Erythropoietin |
| Regulation | 21 CFR 864.7250 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.
Classification Rationale
Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
Special Controls
*Classification.* Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240182 | Access EPO | Beckman Coulter, Inc. | Apr 22, 2024 | SESE |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | Aug 2, 2019 | SESE |
| K052223 | ACCESS EPO ASSAY | Beckman Coulter, Inc. | Oct 6, 2006 | SESE |
| K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | Sangui Biotech, Inc. | Jun 7, 2000 | SESE |
| K983203 | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 | Diagnostic Products Corp. | Jul 12, 1999 | SESE |
| K980737 | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY | Nichols Institute Diagnostics | Mar 23, 1999 | SESE |
| K952559 | ERYTHROPOIETIN IMMUNOASSAY KIT | Nichols Institute | May 29, 1996 | SESE |
| K954898 | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) | Genzyme Corp. | Feb 5, 1996 | SESE |
| K936016 | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | R&D Systems, Inc. | Jul 19, 1994 | SESE |
| K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS | R&D Systems, Inc. | Apr 21, 1994 | SESE |
| K932650 | ERYTHROPOIETIN IMMUNOASSAY KIT | Nichols Institute | Mar 11, 1994 | SESE |
| K931666 | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY | R&D Systems, Inc. | Jul 20, 1993 | SESE |
| K926390 | PREDICTA ERYTHROPOIETIN KIT | Genzyme Corp. | Jun 25, 1993 | SESE |
| K910481 | EPO-RIA | Ramco Laboratories, Inc. | Nov 29, 1991 | SESE |
| K903492 | DSL ERYTHROPOIETIN (DSL # 1100) | Diagnostic Systems Laboratories, Inc. | Oct 26, 1990 | SESE |
| K902639 | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) | Incstar Corp. | Aug 22, 1990 | SESE |
| K893393 | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) | Incstar Corp. | Nov 21, 1989 | SESE |
| K894943 | CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 | Amgen, Inc. | Oct 10, 1989 | SESE |
| K882686 | ERYTHROPOIETIN ENZYME IMMUNOASSAY | Amgen, Inc. | Dec 20, 1988 | SESE |
| K833957 | ERYTHROPOIETIN EIA | Jcl Clinical Research Corp. | Mar 23, 1984 | SESE |
Top Applicants
- R&D Systems, Inc. — 3 clearances
- Nichols Institute — 2 clearances
- Incstar Corp. — 2 clearances
- Genzyme Corp. — 2 clearances
- Beckman Coulter, Inc. — 2 clearances
