21 CFR 866.5900 — System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5900
Identification
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.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NUA | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection | 2 | 12 | |
| PFR | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection | 2 | 1 | |
| PFS | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection | 2 | 1 |
Special Controls
NUA — System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
eCFR
NUA — System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
Ecfr Llm
PFR — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
eCFR
PFS — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
eCFR
