# LKO: Anti-Rnp Antibody, Antigen And Control

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 23
- Recalls: 0 (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)
- 1996: 2
- 1998: 2
- 1999: 2
- 2000: 1
- 2002: 1
- 2007: 1
- 2009: 1
- 2013: 1
- 2014: 1
- 2019: 1

## Most-cited predicates
- K993589: Varelisa RNP Antibodies (1999), cited by 4
- K984476: Liquichek Anti-RNP Control, Eia, Model 207 (1998), cited by 1
- K123261: Euroimmun Anti-NRNP/SM Elisa (Igg) (2013), cited by 1
- K071210: Modification to Fidis Connective 10*, Model MX006 (2007), cited by 1
- K083117: Elia RNP70 Immunoassay, Elia Sci-70 Immunoassay and Elia JO-1 Immunoassay, Models 14-5511-01, 14-5506-01 and 14-5507-01 (2009), cited by 1

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