Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8

Q: What is the product code of K090901?

The FDA product code is NUA – System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, a Class II (moderate risk) device regulated under 21 CFR 866.5900.

FDA 510(k) K090901 · Osmetech Molecular Diagnostics

Substantially Equivalent

510(k) numberK090901

Submission

Device name: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8
Applicant: Osmetech Molecular Diagnostics
Pasadena, CA, US
Received: April 1, 2009
Decision date: July 6, 2009
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NUA – System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5900
Specialty: Immunology

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…

Other 510(k)s with product code NUA

510(k)	Device	Applicant	Decision
K163347	xTAG Cystic Fibrosis 39 Kit v2NUA · Special	Luminex Molecular Diagnostics, Inc.	12/15/2016SESK
K163336	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA · Special	Luminex Molecular Diagnostics, Inc.	12/15/2016SESK
K083845	Xtag CF60 Kit V2NUA · Traditional	Luminex Molecular Diagnostics, Inc.	12/11/2009SE
K083846	Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267NUA · Traditional	Luminex Molecular Diagnostics, Inc.	09/01/2009SE
K083294	Verigene CFTR Nucleic Acid Test and Verigene CFTR Polyt Nucleic Acid TestNUA · Traditional	Nanosphere, Inc.	07/24/2009SE
K063787	Inplex CF Molecular TestNUA · Traditional	Third Wave Technologies, Inc.	03/13/2008SE
K062028	Cystic Fibrosis Genotyping Assay, Model 6L20-01NUA · Traditional	Celera Diagnostics	09/07/2007SE
K060627	Tag-It Cystic Fibrosis KitNUA · Special	Tm Bioscience Corporation	06/07/2006SE
K060543	Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800NUA · Special	Clinical Micro Sensors, Inc.	03/28/2006SE
K051435	Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 DNA Detection System…NUA · Traditional	Clinical Micro Sensors	01/19/2006SE

More from Clinical Micro Sensors

510(k)	Device	Decision
K093974	Esenor Fii-Fv-Mthfr Genotyping Test, Esenor Fii-Fv Genotyping Test, Esenor Fii GenotypingNPQ · Traditional	04/22/2010SE
K073720	Esensor Warfarin Sensitivity and XT-8 InstrumentODW · Traditional	07/17/2008SE

Questions and answers

When was Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8 cleared by the FDA?

Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8 (K090901) received a 510(k) decision of Substantially Equivalent on July 6, 2009, 96 days after the submission was received.

What is the product code of K090901?

The FDA product code is NUA – System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, a Class II (moderate risk) device regulated under 21 CFR 866.5900.