# Nanosphere, Inc.

- Location (FDA's records): Northbrook, IL
- FDA decisions: 16 (2007–2015): 15 510(k) clearances and 1 De Novo grant
- Product codes: OCC (6), PAM (2), NQX (1), PEN (1), NSU (1), NTI (1), PCH (1), ODW (1), NUA (1), OZN (1)
- Predicates its devices cite: 22 (5 its own); citations of its devices by later devices: 19 (5 its own)
- Recalls linked to its devices: 33 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biofire Diagnostics, LLC: 3 (https://510kreport.com/company/biofire-diagnostics)
- Idaho Technology, Inc.: 3 (https://510kreport.com/company/idaho-technology)
- Roche Diagnostics Corp.: 3 (https://510kreport.com/company/roche-diagnostics)
- Prodesse, Inc.: 2 (https://510kreport.com/company/prodesse)
- Gen-Probe Prodesse, Inc.: 1 (https://510kreport.com/company/gen-probe-prodesse)
- Autogenomics, Incorporated: 1 (https://510kreport.com/company/autogenomics)
- Luminex Molecular Diagnostics, Inc.: 1 (https://510kreport.com/company/luminex-molecular-diagnostics)
- Third Wave Technologies, Inc.: 1 (https://510kreport.com/company/third-wave-technologies)

## Firms that cite its devices most
- Luminex Corporation: 2 (https://510kreport.com/company/luminex)
- Hologic, Inc.: 2 (https://510kreport.com/company/hologic)
- Icubate, Inc.: 2 (https://510kreport.com/company/icubate)
- Great Basin Scientific, Inc.: 2 (https://510kreport.com/company/great-basin-scientific)
- Janssen Pharmaceutica NV: 1 (https://510kreport.com/company/janssen-pharmaceutica)
- Intelligent Medical Devices, Inc.: 1 (https://510kreport.com/company/intelligent-medical-devices)
- Trimgen Corporation: 1 (https://510kreport.com/company/trimgen)
- Roche Molecular Systems, Inc.: 1 (https://510kreport.com/company/roche-molecular-systems)

## Its most-cited devices
- K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test (2012), cited by 4
- K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test (2007), cited by 3
- K092566: Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp) (2009), cited by 2
- DEN120014: Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) (2012), cited by 2
- K103209: Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) (2011), cited by 2
- K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) (2014), cited by 2

## Recent decisions
- K143653: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (Sep 4, 2015)
- K140083: Verigene Enteric Pathogen Nucleic Acid Test ( EP) (Jun 20, 2014)
- K132843: Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) (Jan 8, 2014)
- K123197: Verigene C. Difficile Nucleic Acid Test (CDF) (Dec 5, 2012)
- K120466: Verigene CYP2C19 Nucleic Acid Tes (2C19) (Nov 6, 2012)
- K122514: Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid Test (Sep 19, 2012)
- DEN120014: Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) (Jun 26, 2012)
- K112424: Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S) (Dec 16, 2011)

Source page: https://510kreport.com/company/nanosphere