Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nanosphere, Inc. — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

120 daysmedian FDA review time
256 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K143653Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP FlNanosphere, Inc.2015-09-042551
K140083VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)Nanosphere, Inc.2014-06-201582
K132843VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GNanosphere, Inc.2014-01-081205
K123197VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)Nanosphere, Inc.2012-12-05553
K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)Nanosphere, Inc.2012-11-062651
K122514VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TENanosphere, Inc.2012-09-19336
DEN120014VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GNanosphere, Inc.2012-06-26110
K112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-Nanosphere, Inc.2011-12-161150
K103209VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)Nanosphere, Inc.2011-01-10701
K093337VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENENanosphere, Inc.2009-11-17220
K092957VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TESNanosphere, Inc.2009-10-21260
K092566VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENENanosphere, Inc.2009-10-09500
K083294VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLNanosphere, Inc.2009-07-242560
K083088VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TESTNanosphere, Inc.2009-05-011970
K070597VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST,Nanosphere, Inc.2007-10-112230
K070804VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TNanosphere, Inc.2007-09-171781

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda