# DEW: Igg, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5510; FDA's rule: 510(k) required
- FDA decisions: 76
- Recalls: 3 (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)
- 1994: 2
- 1995: 1
- 1996: 2
- 1997: 3
- 1998: 1
- 1999: 1
- 2000: 1
- 2001: 1
- 2004: 1
- 2005: 1

## Most-cited predicates
- K951635: Beckman Immunoglobulin G (Igg) Reagent, Urine Application, Urine Protein Calibrator, Control (1995), cited by 3
- K963868: Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) (1997), cited by 2
- K891385: Vitek Immunodiagnostic Assay System (Vidas) (1989), cited by 2
- K800119: Immunoglobulin G Reagent System (1980), cited by 1
- K833402: Tech. RA-1000SYS-Analytes Immunoglobulin (1984), cited by 1
- K050113: Tina-Quant Igg Gen.2 (2005), cited by 1
- K963974: Image-Immunochemistry System Urine Immunoglobulin (1997), cited by 1
- K862764: Tina-Quant (R) Igg (1986), cited by 1
- K943997: Behring Nephelometer II (1994), cited by 1

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