# OOI: Real Time Nucleic Acid Amplification System

- Device class: 2; regulation: 21 CFR 862.2570; FDA's rule: 510(k) exempt
- FDA decisions: 14
- 510(k) review time 2021–2025: median 134 days (middle half 112–139)
- Recalls: 14 (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: 3
- 2012: 1
- 2013: 1
- 2014: 1
- 2015: 2
- 2016: 2
- 2017: 1
- 2022: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K092705: Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501 (2010), cited by 2
- K151690: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (2015), cited by 1
- K220480: Revogene (2022), cited by 1
- K222779: Revogene (2023), cited by 1
- K093383: Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag (2010), cited by 1
- K170558: revogene (2017), cited by 1

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