# GGP: Test, Qualitative And Quantitative Factor Deficiency

- Device class: 2; regulation: 21 CFR 864.7290; FDA's rule: 510(k) required
- FDA decisions: 190
- 510(k) review time 2021–2025: median 260 days (middle half 108–367)
- Recalls: 10 (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)
- 2008: 2
- 2009: 1
- 2011: 1
- 2014: 1
- 2018: 1
- 2019: 1
- 2020: 2
- 2022: 2
- 2023: 2
- 2025: 1

## Most-cited predicates
- K833892: Coatest Factor Viii (1984), cited by 3
- K922201: Coamate Protein C Chromogenic Assay (1992), cited by 3
- K913424: Staclot (R) Protein S Test Kit (1991), cited by 3
- K912711: IL Test Proclot Assay Stystem (1991), cited by 3
- K010963: Sta-Liatest Free Protein S Test Kit (2001), cited by 2
- K934314: Tintelizer (R) Tpa (1994), cited by 2
- K000398: Shield Von Willebrand Factor Activity Elisa, Model FVWF 200 (2000), cited by 2
- K930327: IL Test (TM) Protein S (1993), cited by 2
- K861417: Assera-Plate VWF Kit (1986), cited by 1
- K981038: Coamatic Factor Viii (1998), cited by 1

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