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U.S. Department of Health and Human Services

Medical Devices

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Tag-It™ Cystic Fibrosis Kit - K043011

This is a brief overview of information related to FDA’s clearance to market this product. 


Product Name: Tag-It™ Cystic Fibrosis Kit
Manufacturer: Tm Bioscience Corporation
Address: 439 University Ave., Suite 900, Toronto, Ontario M5G 1Y8
Approval Date: May 9, 2005 (Approved Evaluation of Automatic Class III Designation)
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k043011.pdf

What is it? The Tag-It™ Cystic Fibrosis Kit is a laboratory test system that is used to detect and identify a group of variations in the gene called cystic fibrosis transmembrane conductance regulator (CFTR) in human blood specimens. Variations in CFTR gene have been found to cause the genetic disease, cystic fibrosis.

Cystic fibrosis (CF) is the most common cause of chronic lung disease in children and young adults, and the most common fatal hereditary disorder affecting Caucasians in the US . Half of the people with CF die by the age of 30. CF affects about one in 2500-3300 Caucasian babies. The disease mainly affects the lungs. Thick mucus in the lungs prevents normal breathing, leads to infections and results in loss of the lungs' ability to function. Digestive and reproductive systems, as well as sweat glands (resulting in excess salt loss), may also be involved. The CFTR gene causing CF was discovered in 1989.

How does it work?

  • A sample of blood is collected and taken to the lab.
  • The lab separates DNA from the cells in the blood sample.
  • The lab prepares the DNA and mixes the DNA with reagents provided in the Tag-It™ Cystic Fibrosis Kit.
  • The Tag-It™ Cystic Fibrosis test system processes the DNA and reads the test result.
  • The doctor uses the CFTR test result to help him determine whether the patient has any of the CFTR gene variations.

When is it used? The Tag-It™ Cystic Fibrosis Kit is used to test:

  • adults of reproductive age to determine whether they have one of the CFTR gene variations,
  • newborns to test for these variations,
  • children with symptoms of CF.

Since the Tag-It™ Cystic Fibrosis Kit detects a limited number of mutations (out of more than 1300 mutations identified in the CFTR gene), it should not be used alone to diagnose cystic fibrosis. The clinical condition of the patient should be considered when interpreting the CFTR test results.

Interpretation of test results depends on many factors, such as patient demographics and family history. This test is not a substitute for your doctor’s judgment and clinical experience. Genetic counseling might be needed because of the wide clinical presentation due to variable genotype-phenotype relationship for different mutations.

What will it accomplish? The Tag-It™ Cystic Fibrosis Kit is used to determine if a patient has mutations in his/her CFTR gene and help a doctor to diagnose or confirm that the patient has CF. In the case of carrier testing, it can help identify couples where one or both partners are carriers of an abnormal CFTR gene.

When should it not be used? The Tag-It™ Cystic Fibrosis Kit should not be used:

  • In testing of fetus or pre-implantation.
  • Alone to diagnose CF. Other clinical information and patient history have to be considered.

Additional information: 
FDA Substantial Equivalence letter is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k043011.pdf