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510(k) K122514

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST by Nanosphere, Inc. — Product Code PAM

K122514 is an FDA 510(k) premarket notification submitted by Nanosphere, Inc. for the device "VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST". The FDA issued a decision of Substantially Equivalent on September 19, 2012. The device falls under product code PAM (Gram-Positive Bacteria And Their 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
September 19, 2012
Date Received
August 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant 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)
  • K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
  • K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (December 5, 2012)
  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 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 PAM

  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (December 20, 2018)
  • K163390 — iC-GPC Assay TM for use on the iC-SystemTM (August 8, 2017)
  • K152470 — Great Basin Staph ID/R Blood Culture Panel (March 25, 2016)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)

FDA data resources