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510(k) K120466

VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) by Nanosphere, Inc. — Product Code NTI

K120466 is an FDA 510(k) premarket notification submitted by Nanosphere, Inc. for the device "VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)". The FDA issued a decision of Substantially Equivalent on November 6, 2012. The device falls under product code NTI (Drug Metabolizing Enzyme Genotyping Systems), a Class II device regulated under 21 CFR 862.3360. Nanosphere, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2012
Date Received
February 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Metabolizing Enzyme Genotyping Systems
Device Class
Class II
Regulation Number
862.3360
Review Panel
TX
Submission Type

Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.

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)
  • 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 NTI

  • K220026 — Genomadix Cube CYP2C19 System (March 21, 2023)
  • K170492 — xTAG CYP2D6 Kit v3 (August 11, 2017)
  • K131565 — XTAG CYP2C19 KIT V3 (September 11, 2013)
  • K123891 — SPARTAN RX CYP2C19 TEST SYSTEM (August 12, 2013)
  • K130189 — XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) (May 21, 2013)
  • K101683 — INFINITI CYP2C19 ASSAY (October 25, 2010)
  • K093420 — XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0 (August 26, 2010)
  • K051824 — INVADER UGT1A1 MOLECULAR ASSAY (August 18, 2005)
  • K043576 — ROCHE AMPLICHIP CYP450 TEST (January 10, 2005)
  • DEN040011 — AMPLICHIP CYP450 TEST, MODEL 04381866190 (December 23, 2004)

FDA data resources