# MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

- Device class: 2; regulation: 21 CFR 866.5660; FDA's rule: 510(k) required
- FDA decisions: 75
- 510(k) review time 2021–2025: median 149 days (middle half 149–149)
- Recalls: 1 (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)
- 2006: 4
- 2007: 1
- 2009: 2
- 2010: 6
- 2012: 1
- 2014: 1
- 2017: 1
- 2018: 3
- 2025: 1
- 2026: 1

## Most-cited predicates
- K961340: Nova Lite Anca (1996), cited by 4
- K954062: Eia Kit for the Detection of Anti-Mpo Antibodies (1996), cited by 2
- K981030: Bindazyme Anti-Mpo Enzyme Immunoassay Kit (1998), cited by 2
- K981029: Bindazyme Anti-PR3 Enzyme Immunoassay Kit (1998), cited by 2
- K954105: Eia Kit for the Detction of Anti-PR3 Antibodies (1996), cited by 2
- K083850: Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems (2009), cited by 1
- K070458: Modification to Fidis Vasculitis, Model MX007 (2007), cited by 1
- K040111: Zeus Scientific, Inc., Athena Multi-Lyte Mpo/PR3 Igg Test System (2004), cited by 1
- K981330: Quanta Lite Mpo Igg (Myeloperoxidase) Test Kit (1998), cited by 1
- K041040: Varelisa Mpo Anca, Model 17648/17696 (2004), cited by 1

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