Nanosphere, Inc.: FDA clearances and approvals
Nanosphere, Inc. has 15 FDA 510(k) clearances (first 2007, latest 2015), plus 1 De Novo decision, across 10 product codes in 4 review panels. Median 510(k) review time: 120 days. openFDA lists 12 product recalls by a recalling firm named Nanosphere, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 55 |
| 2013 | 0 | — |
| 2014 | 2 | 139 |
| 2015 | 1 | 255 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 6 | 6 |
| PAM | Gram-Positive Bacteria And Their Resistance Markers | 2 | 1 |
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 1 | 1 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 1 | 1 |
| NTI | Drug Metabolizing Enzyme Genotyping Systems | 1 | 1 |
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | 1 | 1 |
| ODW | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System | 1 | 1 |
| OZN | C. Difficile Toxin Gene Amplification Assay | 1 | 1 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 1 | 1 |
| PEN | Gram-Negative Bacteria And Associated Resistance Markers | 1 | 1 |
Review panels
- Microbiology (12)
- Clinical Toxicology (2)
- Clinical Chemistry (1)
- Pathology (1)
Most recent Nanosphere, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | OCC | 2015-09-04 | 255 |
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) | PCH | 2014-06-20 | 158 |
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | PEN | 2014-01-08 | 120 |
| K123197 | VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) | OZN | 2012-12-05 | 55 |
| K120466 | VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) | NTI | 2012-11-06 | 265 |
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | PAM | 2012-09-19 | 33 |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | NQX | 2011-12-16 | 115 |
| K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) | OCC | 2011-01-10 | 70 |
| K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM | OCC | 2009-11-17 | 22 |
| K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | OCC | 2009-10-21 | 26 |
5 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN120014 | De Novo | Gram-Positive Bacteria And Their Resistance Markers | 2012-06-26 |
Recalls
12 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2014-07-09.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Nanosphere, Inc. have?
Nanosphere, Inc. has 15 FDA 510(k) clearances (first 2007, latest 2015), plus 1 De Novo decision, across 10 product codes in 4 review panels.
How long does FDA take to clear Nanosphere, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Nanosphere, Inc.'s cleared 510(k)s is 120 days.
What devices does Nanosphere, Inc. make?
Its most frequent FDA product codes are OCC (Respiratory Virus Panel Nucleic Acid Assay System, 6); PAM (Gram-Positive Bacteria And Their Resistance Markers, 2); NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen, 1).
Has Nanosphere, Inc. had device recalls?
openFDA lists 12 product recalls in 7 recall events by a recalling firm whose name matches Nanosphere, Inc; the most recent began 2014-07-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Nanosphere, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCC, Nanosphere, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.