510(k) Report

FDA product code · Pathology

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

NUAClass II21 CFR 866.5900510(k) required12 decisions since 20050 recalls

12 FDA decisions since 2005. No recall names this code. The most-cited predicate is DEN050004, named by 6 later devices.

The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or…

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

FIG. A — Illustration, pathology panel

Twenty years of NUA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — NUA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NUA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NUA devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN050004Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 20056cite it
  • K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800Clinical Micro Sensors · 20062cite it
  • K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 20092cite it
  • K060627Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 20062cite it
  • K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument…Osmetech Molecular Diagnostics · 20091cites it
  • K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 20061cites it

Which NUA devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument…Osmetech Molecular Diagnostics · 20093generations
  • K083845Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 20092generations
  • K083846Xtag Cystic Fibrosis 39 Kit V2, (CFTR 39 Kit V2), Model I027C0231, I027D0266, I027E0267Luminex Molecular Diagnostics, Inc. · 20092generations
  • K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 20062generations
  • K063787Inplex CF Molecular TestThird Wave Technologies, Inc. · 20081generation
  • K062028Cystic Fibrosis Genotyping Assay, Model 6L20-01Celera Diagnostics · 20071generation

What has FDA decided in NUA lately?

  • K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRLuminex Molecular Diagnostics, Inc. · 2016
  • K163347xTAG Cystic Fibrosis 39 Kit v2Luminex 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
  • K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument…Osmetech Molecular Diagnostics · 20092 recalls

All 12 NUA decisions →

Related product codes

Other codes under 21 CFR 866.5900.

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