# LSW: Anti-Dna Antibody, Antigen And Control

- Device class: 2; regulation: 21 CFR 866.5100; FDA's rule: 510(k) required
- FDA decisions: 8
- 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)
- 1987: 1
- 1993: 1
- 2004: 1
- 2006: 1
- 2007: 1
- 2008: 1
- 2016: 1
- 2018: 1

## Most-cited predicates
- K152013: QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (2016), cited by 1
- K072393: Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01 (2007), cited by 1

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