# DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 110
- 510(k) review time 2021–2025: median 654 days (middle half 654–654)
- Recalls: 7 (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)
- 2002: 2
- 2003: 10
- 2004: 1
- 2007: 1
- 2012: 1
- 2014: 1
- 2015: 2
- 2016: 2
- 2018: 1
- 2022: 1

## Most-cited predicates
- K813592: Quantafluor Fluorescent Test Reagents (1982), cited by 4
- K872845: Bion Antinuclear Antibody (Ana)Test Kit/Contr Serum (1987), cited by 2
- K972145: Hep-2000 Fluorescent Ana-RO Test System (1998), cited by 2
- K984397: Liquichek Ana Control, Centromere Pattern, Model 203 (1998), cited by 2
- K780899: Fluorescent Anti-Native Dna Test (1978), cited by 2
- K880742: Nova Lite (TM) Dsdna (1988), cited by 1
- K771376: Ifa Anti-Ndna (1977), cited by 1
- K013213: Hyperion Visiquant Ana Test Kit (2002), cited by 1
- K874873: Combigene (TM) Anti-Dna #Kaddz, KADD1 (1988), cited by 1

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