# DHA: System, Test, Human Chorionic Gonadotropin

- Device class: 2; regulation: 21 CFR 862.1155; FDA's rule: 510(k) required
- FDA decisions: 72
- 510(k) review time 2021–2025: median 179 days (middle half 128–309)
- Recalls: 12 (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)
- 2009: 1
- 2013: 2
- 2015: 1
- 2017: 2
- 2019: 1
- 2020: 1
- 2021: 3
- 2022: 1
- 2023: 3
- 2024: 1

## Most-cited predicates
- K941090: Unistep HCG Pregnancy Test Strip (1994), cited by 3
- K983424: Abbott Archeitect Total B-HCG (1998), cited by 3
- K003178: Elecsys HCG and Beta Test System (2000), cited by 2
- K130020: Access Total BHCG (5TH IS) (2013), cited by 2
- K170317: Alinity i Total ß-hCG Reagent Kit, Alinity i System (2017), cited by 1
- K002148: Elecsys HCG Test System (2000), cited by 1
- K970387: Human Chorionic Gonadotropin Method (1997), cited by 1
- K060548: Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and Dilpak (2006), cited by 1
- K911796: Immulite (TM) HCG (1991), cited by 1
- K970894: Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG Calibrators (Gem.C075) (1997), cited by 1

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