# DGC: Ige, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 114
- 510(k) review time 2021–2025: median 403 days (middle half 232–412)
- Recalls: 2 (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)
- 2003: 2
- 2004: 2
- 2005: 1
- 2007: 1
- 2014: 1
- 2016: 1
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K964152: Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH (1997), cited by 3
- K920372: Acs Total Ige Immunoassay (1992), cited by 2
- K991787: N Latex Ige Mono Reagent (1999), cited by 1
- K161899: ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls (2016), cited by 1
- K832218: Allergen Control Inhalent (1983), cited by 1
- K933180: Quanta Lite Mitochondria M2 Elisa (1993), cited by 1
- K991945: Pharmacia Cap System Ige Feia, Model 10-9395-01 (1999), cited by 1
- K890530: N Latex Ige Kit (Immunoglobulin E Reagents) (1989), cited by 1
- K133404: Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH (2014), cited by 1
- K050493: Quantia Ige (2005), cited by 1

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