# K083845: Xtag CF60 Kit V2

- Pathway: 510(k) (Traditional)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Dec 11, 2009 after 352 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
Longest line of descent: 2 generations back to DEN050004 (2005). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN050004: Tag-IT Cystic Fibrosis Kit, Tm Bioscience Corporation (2005). Our reading of the summary gave K043011, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN050004, Tag-IT Cystic Fibrosis Kit (Tm Bioscience Corporation), granted May 9, 2005; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K060627: Tag-IT Cystic Fibrosis Kit, Tm Bioscience Corporation (2006) Summary page 2.

## Most influential descendants
- K124006: Illumina Miseqdx  Cystic Fibrosis 139-Variant Assay (2013), 0 descendants of its own
- K132750: Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay (2013), 0 descendants of its own

## 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 which 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/K083845
Methodology: https://510kreport.com/methodology