510(k) K163347

xTAG Cystic Fibrosis 39 Kit v2 by Luminex Molecular Diagnostics, Inc. — Product Code NUA

Clearance Details

Decision: SESK (Substantially Equivalent (kit))
Decision Date: December 15, 2016
Date Received: November 28, 2016
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Device Class: Class II
Regulation Number: 866.5900
Review Panel: PA
Submission Type

The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.

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)
K170492 — xTAG CYP2D6 Kit v3 (August 11, 2017)
K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR (December 15, 2016)
K152386 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT (December 17, 2015)

Other clearances for product code NUA

K163336 — xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR (December 15, 2016)
K083845 — XTAG CF60 KIT V2 (December 11, 2009)
K083846 — XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I0 (September 1, 2009)
K083294 — VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST (July 24, 2009)
K090901 — ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING T (July 6, 2009)
K063787 — INPLEX CF MOLECULAR TEST (March 13, 2008)
K062028 — CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 (September 7, 2007)
K060627 — TAG-IT CYSTIC FIBROSIS KIT (June 7, 2006)
K060543 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 (March 28, 2006)
K051435 — ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYST (January 19, 2006)