This is a brief overview of information related to FDA’s clearance to market this product.
Product Name: INTROL™ CF Panel I Control
Manufacturer: Maine Molecular Quality Controls, Inc. (MMQCI)
Address: 10 Southgate Road, Suite 170, Scarborough, ME 04074
Approval Date: September 18, 2006 (Approved Evaluation of Automatic Class III Designation)
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/k060070.pdf
What is it? INTROL™ CF Panel I Control is DNA quality control material that is used to monitor the performance of genetic tests used in the detection 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.
Detection of 38 CFTR gene variations can be monitored at the same time using INTROL™ CF Panel I Control, including CFTR mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG).
How does it work? INTROL™ CF Panel I Control is a quality control material that is processed in the same way as the patient blood sample tested:
- The lab separates DNA from the other substances in the blood sample and in the control material.
- The lab prepares the DNA and mixes the DNA with reagents used in the test.
- The test is carried out and the lab reads the test result.
- If the INTROL™ CF Panel I Control gives the expected result this signals that the test is running properly.
When is it used? The INTROL™ CF Panel I Control is used as a control with genetic tests used in the detection of variations in the CFTR gene in human blood specimens.
What will it accomplish? The INTROL™ CF Panel I Control monitors reliability of genetic tests and helps minimize reporting of incorrect results.
510(k) Decision Summary and labeling will be available at: http://www.accessdata.fda.gov/cdrh_docs/pdf6/k060070.pdf
Additional information on cystic fibrosis:
Brief description of CFTR gene :
CFTR gene allelic variants:
The Cystic Fibrosis Foundation: