# NHX: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

- Device class: 2; regulation: 21 CFR 866.5775; FDA's rule: 510(k) required
- FDA decisions: 21
- 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)
- 2005: 2
- 2006: 2
- 2007: 2
- 2008: 2
- 2009: 2
- 2010: 3
- 2011: 2
- 2013: 1
- 2015: 1
- 2016: 1

## Most-cited predicates
- K023285: Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa (2002), cited by 5
- K052133: Immunoscan RA Anti-CCP Test System (2005), cited by 4
- K081338: Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP (2008), cited by 2
- K052264: Quanta Lite CCP3 Igg Elisa (2005), cited by 2
- K083868: Architect Anti-CCP (100 Test), Architect Anti-CCP (500 Test), Models 1P65-25, 1P65-35 (2009), cited by 1
- K061165: Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01 (2006), cited by 1
- K093954: Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection System (2010), cited by 1

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