510(k) K063787
K063787 is an FDA 510(k) premarket notification submitted by Third Wave Technologies, Inc. for the device "INPLEX CF MOLECULAR TEST". The FDA issued a decision of Substantially Equivalent on March 13, 2008. The device falls under product code NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection), a Class II device regulated under 21 CFR 866.5900. Third Wave Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2008
- Date Received
- December 21, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- Device Class
- Class II
- Regulation Number
- 866.5900
- Review Panel
- PA
- Submission Type
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.