# LJM: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 112
- Recalls: 2 (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)
- 2001: 2
- 2002: 1
- 2003: 2
- 2004: 5
- 2005: 2
- 2009: 1
- 2013: 1
- 2014: 3
- 2016: 1
- 2018: 1

## Most-cited predicates
- K944172: Varelisa SCL-70 Antibodies (1994), cited by 2
- K944173: Varelisa JO-1 Antibodies (1994), cited by 2
- K944168: Varelisa LA (SS-B) Antibodies (1994), cited by 2
- K944171: Varelisa Centromere Antibodies (1994), cited by 2
- K993108: Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96 (1999), cited by 2
- K951850: Enzyme Immunoassay Anti-JO-1 Antibody Test Kit (1995), cited by 1
- K962054: Orgentec Anti-SS-a (RO) Elisa (1996), cited by 1
- K040200: Mesacup-2 Test Cenp-B (2004), cited by 1
- K951798: Enzyme Immunoassay Anti-Sci-70 Antibody Test Kit (1995), cited by 1
- K944169: Varelisa RO (SS-a) Antibodies (1994), cited by 1

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