510(k) K132750
K132750 is an FDA 510(k) premarket notification submitted by Illumina, Inc. for the device "ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY". The FDA issued a decision of Substantially Equivalent on November 19, 2013. The device falls under product code PFS (System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence 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
- September 3, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
- Device Class
- Class II
- Regulation Number
- 866.5900
- Review Panel
- PA
- Submission Type
The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes