Gene Mutation Detection System

Published On -

I3CGlobal IVDR, FDA 510k

FDA 510K for Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System

A Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System is a laboratory technique used to identify genetic variations (mutations) within the CFTR gene, which is responsible for cystic fibrosis, allowing for diagnosis of the disease and carrier screening by detecting specific mutations in a person’s DNA sample, typically from blood or saliva.

Intended Use of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System

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.

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System 
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FDA 510K for Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System Device Code and Regulation Number

Sl. No

Product Code

Device

Regulation Description

Regulation Number

Class

1.

NUA

 System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System.

866.5900

2

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Intended Use:

It is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children.

Device Description:

This device is a genetic analysis system that uses molecular biology methods to detect mutations and variants in the CFTR gene, which are associated with cystic fibrosis. The specific reagents, workflow, and detection method depend on assay design but share these core components and principles:

  1. Sample Preparation.
  2. Amplification:
  3. Detection and Genotyping
  4. Software and Data Interpretation
  5. Controls.

 

Performance Testing (Analytical Nonclinical) for Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System

  • precision/Reproducibility
  • Linearity/assay reportable range
  • Detection limit
  • Analytical specificity
  • Traceability (controls, calibrators, or method)
  • Interference
  • Analytical Sensitivity

Clinical Testing

No Guidance available for 510k submission

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