# GGT: Assay, Erythropoietin

- Device class: 2; regulation: 21 CFR 864.7250; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1990: 2
- 1991: 1
- 1993: 2
- 1994: 3
- 1996: 2
- 1999: 2
- 2000: 1
- 2006: 1
- 2019: 1
- 2024: 1

## Most-cited predicates
- K052223: Access Epo Assay (2006), cited by 2
- K902639: Epo-Trac (TM) 125I Radioimmunoassay (Ria) (1990), cited by 1
- K936016: Quantikine Ivd Erythropoietin Enzyme Linked Immunosorbent Assay (Elisa) (1994), cited by 1
- K952559: Erythropoietin Immunoassay Kit (1996), cited by 1
- K983203: Immulite Epo, Model #'S Lkepz & LKEP1 (1999), cited by 1
- K992799: Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit (2000), cited by 1
- K980737: Advantage Chemiluminescence Erythropoietin Immunoassay (1999), cited by 1

Source page: https://510kreport.com/product-code/GGT
Data by year (CSV): https://510kreport.com/product-code/GGT.csv