510(k) Report

510(k) · Cleared

Cleared

Tag-IT Cystic Fibrosis Kit

K060627510(k) SpecialCleared Jun 7, 200690-day reviewClass II21 CFR 866.5900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tm Bioscience Corporation · NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Cleared on Jun 7, 2006 as substantially equivalent to DEN050004 (Tm Bioscience Corporation, 2005) after a 90-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it.

Decided
Jun 7, 2006
Review
90 days
Class
Class II
Product code
NUA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN050004 (2005). 4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2013: 2 descendants clearedDEN050004 · Tag-IT Cystic Fibrosis Kit · Tm Bioscience Corporation · 200520052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants DEN050004 · Tag-IT Cystic Fibrosis Kit · Tm Bioscience Corporation · 20050
  1. Root · 1 generation backDEN050004 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005
  2. This deviceK060627 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2006
  3. Descendant · cites it directly · 2 of its ownK083845 Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 2009
  4. Descendant · 2 generations on · 0 of its ownK124006 Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc. · 2013
  5. Descendant · 2 generations on · 0 of its ownK132750 Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc. · 2013 · Recalled
  6. Descendant · cites it directly · 0 of its ownK083846 Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231…Luminex Molecular Diagnostics, Inc. · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 2009 · cites it directly2descendants
  • K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc. · 2013 · 2 generations on0descendants
  • K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc. · 2013 · 2 generations on0descendants
  • K083846Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN050004Tag-IT Cystic Fibrosis KitTm Bioscience Corporation2005—
0 (this device)K060627Tag-IT Cystic Fibrosis KitTm Bioscience Corporation2006—
+1K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc.2009—
+2K124006Illumina Miseqdx Cystic Fibrosis 139-Variant AssayIllumina, Inc.2013—
+2K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc.20132
+1K083846Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266…Luminex Molecular Diagnostics, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201320
FIG. 1 — Lineage of K060627, 2005–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN050004Tag-IT Cystic Fibrosis Kit
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.
Tm Bioscience Corporation2005—

Also cleared against DEN050004: 5 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc.20092
K083846Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc.20090

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?

  • Its one ancestor has no recall.
  • Of its descendants, K083845 (Luminex Molecular Diagnostics, Inc., 2009) has gone furthest, with 2 descendants of its own.
  • 5 other devices also cite its predicate DEN050004.

How does its category compare?

All NUA devices

NUA 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

2007: 12008: 12009: 42016: 2
2007high 4 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUA

254in 2009

2009: 254 days median
2007high 254 (2009)2026

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

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code NUA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
2009425400
20100—00
20110—00
20120—00
20130—01
20140—00
20150—00
20162—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Tag-It TM Cystic Fibrosis Kit 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 worlds most common and North…

Read the full statement (132 words)

The Tag-It TM Cystic Fibrosis Kit 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 worlds most common and North American-prevalent mutations. The Tag-It TM Cystic Fibrosis Kit 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.

Indications for use as stated in the FDA summary.

Also cleared against DEN050004

5 other devices cite the same predicate.

  • K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 2009
  • K083846Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc. · 2009
  • K063787Inplex CF Molecular TestThird Wave Technologies, Inc. · 20081 recall
  • K062028Cystic Fibrosis Genotyping Assay, Model 6L20-01Celera Diagnostics · 2007
  • K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800Clinical Micro Sensors · 2006

More from Tm Bioscience Corporation

2 FDA decisions under this applicant name. See the company

  • DEN050004Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005

Recent decisions in NUA

The NUA category page

  • K163347xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics, Inc. · 2016
  • K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRLuminex Molecular Diagnostics, Inc. · 2016
  • K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 2009
  • K083846Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc. · 2009
  • K083294Verigene CFTR Nucleic Acid Test and Verigene CFTR Polyt Nucleic Acid TestNanosphere, Inc. · 2009

https://510kreport.com/device/K060627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060627: Tag-IT Cystic Fibrosis Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060627

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026