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510(k) K090901

ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 by Osmetech Molecular Diagnostics — Product Code NUA

K090901 is an FDA 510(k) premarket notification submitted by Osmetech Molecular Diagnostics for the device "ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8". The FDA issued a decision of Substantially Equivalent on July 6, 2009. The device falls under product code NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection), a Class II device regulated under 21 CFR 866.5900. Osmetech Molecular Diagnostics has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2009
Date Received
April 1, 2009
Clearance Type
Traditional
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 Osmetech Molecular Diagnostics

  • K093974 — ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII G (April 22, 2010)
  • K073720 — ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (July 17, 2008)

Other clearances for product code NUA

  • 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)
  • 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)
  • 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)

FDA data resources