# OQO: Herpes Simplex Virus Nucleic Acid Amplification Assay

- Device class: 2; regulation: 21 CFR 866.3305; FDA's rule: 510(k) required
- FDA decisions: 12
- 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)
- 2010: 1
- 2011: 3
- 2014: 3
- 2015: 3
- 2017: 1
- 2018: 1

## Most-cited predicates
- K100336: Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711 (2010), cited by 3
- K103798: BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified Dna Assays (2011), cited by 2
- K140198: Imdx HSV-1/2 for Abbott M2000 (2014), cited by 2
- K111951: Isoamp HSV Assay (2011), cited by 1
- K142738: artus HSV-1/2 QS-RGQ MDx Kit (2014), cited by 1

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