# NQX: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 24
- 510(k) review time 2021–2025: median 26 days (middle half 24–27)
- Recalls: 12 (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)
- 2008: 2
- 2009: 1
- 2010: 3
- 2011: 2
- 2012: 2
- 2013: 4
- 2014: 1
- 2016: 1
- 2019: 2
- 2024: 2

## Most-cited predicates
- K071026: BD Geneohm Staphsr Assay (2007), cited by 5
- K042357: Idi-Mrsa Assay (2004), cited by 3
- K033415: Idi-Mrsa (2004), cited by 3
- K133605: BD Max Mrsa XT, BD Max Instrument (2013), cited by 2
- K093346: BD Geneohm Mrsa Acp Assay (2009), cited by 2
- K120138: BD Max Mrsa Assay, BD Max Instrument (2012), cited by 2
- K070462: Xpert Mrsa (2007), cited by 2
- K100822: Xpert Mrsa/SA Nasal Assay (2010), cited by 1
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), cited by 1
- K080837: Xpert Mrsa/SA Ssti Assay (2008), cited by 1

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