510(k) K124006
K124006 is an FDA 510(k) premarket notification submitted by Illumina, Inc. for the device "ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY". The FDA issued a decision of Substantially Equivalent on November 19, 2013. The device falls under product code PFR (System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection), a Class II device regulated under 21 CFR 866.5900. Illumina, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2013
- Date Received
- December 26, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
- Device Class
- Class II
- Regulation Number
- 866.5900
- Review Panel
- PA
- Submission Type
The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.