# CDD: Radioassay, Vitamin B12

- Device class: 2; regulation: 21 CFR 862.1810; FDA's rule: 510(k) required
- FDA decisions: 78
- 510(k) review time 2021–2025: median 165 days (middle half 112–218)
- Recalls: 6 (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)
- 2011: 3
- 2012: 3
- 2013: 1
- 2014: 2
- 2015: 1
- 2016: 2
- 2017: 1
- 2019: 2
- 2022: 1
- 2024: 1

## Most-cited predicates
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer (2004), cited by 5
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck (2006), cited by 4
- K112443: Architect Active B-12 (Holotranscobalamin) (2011), cited by 3
- K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator (2007), cited by 3
- K955436: Access Vitamin B12 Assay (Modification) (1996), cited by 3
- K110413: Power Processor Sample Processing System with Generic Connections (2011), cited by 2
- K973702: Elecsys Vitamin B12 Assay (1997), cited by 1
- K160757: ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (2016), cited by 1
- K110579: Architect B12 Reagents, Architect B12 Calibrators, and Architect B12 Controls (2011), cited by 1
- K121994: Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator (2012), cited by 1

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