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510(k) K132843

VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) by Nanosphere, Inc. — Product Code PEN

K132843 is an FDA 510(k) premarket notification submitted by Nanosphere, Inc. for the device "VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)". The FDA issued a decision of Substantially Equivalent on January 8, 2014. The device falls under product code PEN (Gram-Negative Bacteria And Associated Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Nanosphere, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2014
Date Received
September 10, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram-Negative Bacteria And Associated Resistance Markers
Device Class
Class II
Regulation Number
866.3365
Review Panel
MI
Submission Type

A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.

Other clearances by Nanosphere, Inc.

  • K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (September 4, 2015)
  • K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (June 20, 2014)
  • K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (December 5, 2012)
  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)
  • K112424 — VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) (December 16, 2011)
  • K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (January 10, 2011)
  • K093337 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (November 17, 2009)
  • K092957 — VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (October 21, 2009)

Other clearances for product code PEN

  • K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay (April 18, 2025)
  • K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RF (December 20, 2024)
  • K213236 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 27, 2022)
  • K193519 — BioFire Blood Culture Identification 2 (BCID2) Panel (March 18, 2020)
  • K190341 — iC-GN iC-Cassette for use on the iC-System (June 28, 2019)
  • K182619 — ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (April 12, 2019)
  • K181493 — FilmArray Blood Culture Identification (BCID) Panel (July 5, 2018)
  • K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch (March 15, 2016)
  • K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2 (January 30, 2015)
  • K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL (June 21, 2013)

FDA data resources