# LKJ: Antinuclear Antibody, Antigen, Control

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 50
- 510(k) review time 2021–2025: median 488 days (middle half 488–488)
- Recalls: 11 (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)
- 1998: 5
- 1999: 1
- 2001: 1
- 2002: 2
- 2003: 5
- 2004: 3
- 2008: 1
- 2009: 1
- 2012: 1
- 2022: 1

## Most-cited predicates
- K954723: Enzyme Immunoassay Ana Screening Test Kit (1995), cited by 11
- K081104: Aeskulisa Ana Hep-2, Ref 30-7115US (2008), cited by 2
- K041658: Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex 2200 (2004), cited by 1
- K011244: Zeus Scientific, Inc. Athena Multi-Lyte Ana Test System (2001), cited by 1
- K984470: Liquichek Anti-SS-a Control, Eia, Model 209 (1998), cited by 1
- K082759: Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO Immunoassay (2009), cited by 1
- K984475: Liquichek Anti-SCL-70 Control, Eia, Model 212 (1998), cited by 1
- K984478: Liquichek Anti-SS-B Control, Eia, Model 210 (1998), cited by 1

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