510(k) K170492

xTAG CYP2D6 Kit v3 by Luminex Molecular Diagnostics, Inc. — Product Code NTI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 11, 2017
Date Received: February 17, 2017
Clearance Type: Special
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)
K183023 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GP (November 30, 2018)
K183030 — xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GP (November 30, 2018)
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)
K152386 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT (December 17, 2015)

Other clearances for product code NTI

K220026 — Genomadix Cube CYP2C19 System (March 21, 2023)
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)
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)