# NSU: Instrumentation For Clinical Multiplex Test Systems

- Device class: 2; regulation: 21 CFR 862.2570; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 11 (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)
- 2007: 1
- 2008: 3
- 2010: 1
- 2011: 1
- 2013: 1
- 2014: 3
- 2015: 1
- 2017: 1

## Most-cited predicates
- K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test (2007), cited by 3
- K082562: Applied Biosystems 7500 Fast DX (2008), cited by 2
- K141220: Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software (2014), cited by 1
- K080995: Modification to Affymetrix Genechip Microarray Instrumentation System (2008), cited by 1
- K110786: Esensor Warfarin Sensitivity Saliva Test (2011), cited by 1
- K073506: Luminex LX 100/200 Instrument (2008), cited by 1

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