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510(k) K130189

XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) by Luminex Molecular Diagnostics, Inc. — Product Code NTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2013
Date Received
January 25, 2013
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 Luminex Molecular Diagnostics, Inc.

  • K242613 — NxTAG® Respiratory Pathogen Panel (October 2, 2024)
  • K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) (March 11, 2024)
  • K193167 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT (December 11, 2019)
  • K191161 — xTAG Gastrointestinal Pathogen Panel (GPP) (November 12, 2019)
  • K191160 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GP (November 4, 2019)
  • K183030 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GP (November 30, 2018)
  • K183023 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GP (November 30, 2018)
  • K170492 — xTAG CYP2D6 Kit v3 (August 11, 2017)
  • K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR (December 15, 2016)
  • K163347 — xTAG Cystic Fibrosis 39 Kit v2 (December 15, 2016)

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)
  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
  • 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)