# DEN050004: Tag-IT Cystic Fibrosis Kit

- Pathway: De Novo (Post-NSE)
- Applicant: Tm Bioscience Corporation
- Decided: May 9, 2005 after 34 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.
11 later devices descend from it; 6 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K060627: Tag-IT Cystic Fibrosis Kit (2006), 4 descendants of its own
- K051435: Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800 (2006), 3 descendants of its own
- K083845: Xtag CF60 Kit V2 (2009), 2 descendants of its own
- K063787: Inplex CF Molecular Test (2008), 2 descendants of its own
- K060543: Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800 (2006), 2 descendants of its own

Source page: https://510kreport.com/device/DEN050004
Methodology: https://510kreport.com/methodology