De Novo · Granted
GrantedTag-IT Cystic Fibrosis Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tm Bioscience Corporation · NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Granted on May 9, 2005 as a new device type through De Novo after a 34-day review. 11 later devices descend from it.
- Decided
- May 9, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- NUA
- Recalls
- None
11 later devices descend from it, 6 citing it directly.
- This deviceDEN050004 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005
- Descendant · cites it directly · 4 of its ownK060627 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2006
- Descendant · cites it directly · 3 of its ownK051435 Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna…Clinical Micro Sensors · 2006
- Descendant · cites it directly · 2 of its ownK083845 Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK063787 Inplex CF Molecular TestThird Wave Technologies, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK060543 Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 2006
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K060627Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2006 · cites it directly4descendants
- K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System…Clinical Micro Sensors · 2006 · cites it directly3descendants
- K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 2009 · cites it directly2descendants
- K063787Inplex CF Molecular TestThird Wave Technologies, Inc. · 2008 · cites it directly2descendants
- K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 2006 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN050004 | Tag-IT Cystic Fibrosis Kit | Tm Bioscience Corporation | 2005 | — |
| +1 | K060627 | Tag-IT Cystic Fibrosis Kit | Tm Bioscience Corporation | 2006 | — |
| +1 | K051435 | Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection… | Clinical Micro Sensors | 2006 | — |
| +1 | K083845 | Xtag CF60 Kit V2 | Luminex Molecular Diagnostics, Inc. | 2009 | — |
| +1 | K063787 | Inplex CF Molecular Test | Third Wave Technologies, Inc. | 2008 | 1 |
| +2 | K060543 | Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800 | Clinical Micro Sensors, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060627 | Tag-IT Cystic Fibrosis Kit | 2006 | 4 |
| K051435 | Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System… | 2006 | 3 |
| K083845 | Xtag CF60 Kit V2 | 2009 | 2 |
| K063787 | Inplex CF Molecular Test | 2008 | 2 |
| K083846 | Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267 | 2009 | 0 |
| K062028 | Cystic Fibrosis Genotyping Assay, Model 6L20-01 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060627 (Tm Bioscience Corporation, 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NUA devicesNUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUA
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NUA
254in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUA
No recall names NUA since 2007.
Adverse event reports per year · NUA
1in 2013
MAUDE reports naming product code NUA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 4 | 254 | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN050004 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN050004: Tag-IT Cystic Fibrosis Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN050004
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026