# LKP: Anti-Sm Antibody, Antigen And Control

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 352 days (middle half 352–352)
- 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)
- 1999: 1
- 2000: 2
- 2002: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2013: 1
- 2014: 1
- 2018: 1
- 2021: 1

## Most-cited predicates
- K132631: Eia SMDP Immunoassay (2014), cited by 2
- K042629: Varelisa SM Antibodies, Model 18296 (2004), cited by 2
- K000312: Varelisa SM Antibodies (2000), cited by 2
- K984479: Liquichek Anti-SM Control, Eia, Model 208 (1998), cited by 1
- K954830: Orgentec Anti-SM (Smith) Pin Immuno Assay (1996), cited by 1
- K123593: Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls, (2013), cited by 1

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