# K163336: xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

- Pathway: 510(k) (Special)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Dec 15, 2016 after 17 days
- Product code: NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection)
- Device class: 2
- Regulation: 21 CFR 866.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The xTAG® Cystic Fibrosis 60 Kit v2 is a device used to simultaneously detect and identify a panel of mutations and variants in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. The panel includes mutations and variants currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG), plus some of the world’s most common and North American-prevalent mutations. The xTAG Cystic Fibrosis 60 Kit v2 is a qualitative genotyping test that provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. The kit is not indicated for use in fetal diagnostic or pre-implantation testing. This kit is also not indicated for stand-alone diagnostic purposes.

Source page: https://510kreport.com/device/K163336
Methodology: https://510kreport.com/methodology