# LSL: Dna-Reagents, Neisseria

- Device class: 2; regulation: 21 CFR 866.3390; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 263 days (middle half 263–263)
- Recalls: 5 (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)
- 2006: 4
- 2007: 2
- 2008: 1
- 2009: 3
- 2012: 2
- 2013: 2
- 2014: 3
- 2017: 1
- 2018: 3
- 2024: 1

## Most-cited predicates
- K081825: BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay (2008), cited by 7
- K003395: Gen-Probe Aptima Combo 2 Assay (2001), cited by 4
- K043144: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae (2005), cited by 4
- K984631: Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna Assay (1999), cited by 4
- K043224: Gen-Probe Aptima Combo 2 Assay (2005), cited by 3
- K012351: Bdprobetec ET CT/GC Amplified Dna Assay (2001), cited by 3
- K062440: Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091 (2006), cited by 3
- K121710: Xpert CT/NG (2012), cited by 3
- K173887: cobas CT/NG for use on cobas 6800/8800 systems (2018), cited by 3
- K060652: Tigris DTS Gen-Probe Aptima Combo 2 Assay (2006), cited by 2

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