510(k) Report

FDA applicant

Nanosphere, Inc.

Northbrook, IL16 decisions2007–201533 recalls

FDA records 16 decisions for Nanosphere, Inc. (Northbrook, IL) from 2007 to 2015: 15 510(k) clearances and 1 De Novo grant. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and PAM (Gram-Positive Bacteria And Their Resistance…). Its devices cite 22 predicates, 5 of them its own earlier devices. 33 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Nanosphere, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 22009: 52011: 22012: 42014: 22015: 1
2007high 5 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2008: 12013: 82014: 32018: 32020: 92021: 22022: 22023: 32024: 12025: 1
2007high 9 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nanosphere, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nanosphere, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OCCRespiratory Virus Panel Nucleic Acid Assay System6decisions
  • PAMGram-Positive Bacteria And Their Resistance Markers2decisions
  • NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus…1decision
  • PENGram-Negative Bacteria And Associated Resistance Markers1decision
  • NSUInstrumentation For Clinical Multiplex Test Systems1decision
  • NTIDrug Metabolizing Enzyme Genotyping Systems1decision

Also: PCH (1), ODW (1), NUA (1), OZN (1).

Whose devices does it build on?

Its devices cite 22 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122514Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 20124cite it
  • K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc. · 20073cite it
  • K092566Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)Nanosphere, Inc. · 20092cite it
  • DEN120014Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 20122cite it
  • K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc. · 20112cite it
  • K132843Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 20142cite it

What has FDA decided for it lately?

  • K143653Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc. · 20155 recalls
  • K140083Verigene Enteric Pathogen Nucleic Acid Test ( EP)Nanosphere, Inc. · 20145 recalls
  • K132843Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)Nanosphere, Inc. · 20148 recalls
  • K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc. · 20124 recalls
  • K120466Verigene CYP2C19 Nucleic Acid Tes (2C19)Nanosphere, Inc. · 20121 recall
  • K122514Verigene Gram-Positive Blood Culture (GC-GP) Nucleic Acid TestNanosphere, Inc. · 20128 recalls
  • DEN120014Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc. · 2012
  • K112424Verigene Staphylococcus Blood Culture Nucleic Acid Test (BC-S)Nanosphere, Inc. · 2011

All 16 as Nanosphere, Inc. →

What has been recalled?

33 recalls linked to its devices; the latest:

  • K132843VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use…Apr 16, 2025Class II
  • K122514Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid TestJun 20, 2024Class II
  • K122514Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture…Nov 7, 2023Class II
  • K123197VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022Jun 5, 2023Class II
  • K140083Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023Jun 5, 2023Class II
  • K143653Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene systemApr 5, 2022Class II