INTROL CF PANEL I CONTROL, MODEL: G106
Device Facts
| Record ID | K083171 |
|---|---|
| Device Name | INTROL CF PANEL I CONTROL, MODEL: G106 |
| Applicant | Maine Molecular Quality Controls, Inc. |
| Product Code | NZB · Microbiology |
| Decision Date | Dec 16, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5910 |
| Device Class | Class 2 |
Indications for Use
The Introl™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run. The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG). The INTROL™ CF Panel I Control also monitors 3 polymorphisms (I506V, I507V, F508C) and the 5/7/9T variants.
Device Story
Introl™ CF Panel I Control is an assayed quality control material; consists of synthetic CFTR DNA suspended in a matrix of synthetic DNA targets, non-human carrier DNA, preservatives, dye, and stabilizers. Used in clinical laboratories to monitor analytical performance of CFTR mutation detection assays; processed through extraction, amplification, and detection steps alongside patient samples. Modified version includes 679 additional base pairs of wild-type CFTR sequence to support detection of specific alleles (711+1G>T and 2789+5 G>A). Healthcare providers use control results to verify assay run validity; ensures accurate identification of CFTR mutations/variants for patient diagnosis. Benefits include standardized quality assurance for genetic testing workflows.
Clinical Evidence
No clinical data. Bench testing only. Three batches of modified control were tested using xTAG® (Luminex/TmBioscience), eSensor® CFCD (Osmetech), and InPlex® (Third Wave) assays. Results demonstrated correct genotype calls for all mutations and variants, including successful detection of 711+1G>T and 2789+5 G>A alleles. Lot-to-lot reproducibility was verified across multiple manufacturing builds.
Technological Characteristics
Synthetic recombinant DNA in matrix with non-human carrier DNA, preservatives, dye, and stabilizers. Ready-to-use liquid in polypropylene bottles. Storage at 2-8°C. Modification adds 679 base pairs of wild-type CFTR sequence (Exon 3, 5, and 14b flanking regions).
Indications for Use
Indicated for use as an in vitro diagnostic quality control material to monitor the analytical performance of extraction, amplification, and detection steps in assays identifying CFTR gene mutations and variants in patients undergoing cystic fibrosis testing.
Regulatory Classification
Identification
Quality control material for cystic fibrosis nucleic acid assays. A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.
The device is classified as Class II under regulation 21 CFR 866.5910 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays" is available at http://www.fda.gov/cdrh/oivd/guidance/1614.html.
Predicate Devices
- INTROL™ CF Panel I Control (k060070)
