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510(k) DEN050004

TAG-IT CYSTIC FIBROSIS KIT by Tm Bioscience Corporation — Product Code NUA

DEN050004 is an FDA 510(k) premarket notification submitted by Tm Bioscience Corporation for the device "TAG-IT CYSTIC FIBROSIS KIT". The FDA issued a decision of De Novo Granted on May 9, 2005. 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. Tm Bioscience Corporation has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 9, 2005
Date Received
April 5, 2005
Clearance Type
Post-NSE
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 Tm Bioscience Corporation

  • K060627 — TAG-IT CYSTIC FIBROSIS KIT (June 7, 2006)

Other clearances for product code NUA

  • K163347 — xTAG Cystic Fibrosis 39 Kit v2 (December 15, 2016)
  • 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)

FDA data resources