# MRG: System, Test, Vitamin D

- Device class: 2; regulation: 21 CFR 862.1825; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 195 days (middle half 134–288)
- Recalls: 17 (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)
- 2014: 6
- 2015: 3
- 2016: 3
- 2017: 3
- 2018: 2
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 2
- 2024: 1

## Most-cited predicates
- K071480: Liaison 25 OH Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models 310600, 310601 and 310602 (2007), cited by 6
- K112725: Liaison 25 OH Vitamin D Total Assay (2012), cited by 6
- K021163: Octeia 25-Hydroxy Vitamin D (2002), cited by 6
- K162840: Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (2017), cited by 3
- K032844: Liaison 25 OH Vitamin D (2004), cited by 3
- K110619: Architect 25-OH Vitamin D 100T, Vitamin D 500T, Vitamin D Calibrators, Vitamin D Controls (2011), cited by 3
- K091849: Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set (2010), cited by 3
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), cited by 2
- K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers (2014), cited by 2
- K110586: Advia Centaur Vitamin D Total Assay (2011), cited by 2

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