510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Inplex CF Molecular Test

K063787510(k) TraditionalCleared Mar 13, 2008448-day reviewClass II21 CFR 866.5900Recalls 1

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

Third Wave Technologies, Inc. · NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Cleared on Mar 13, 2008 as substantially equivalent to DEN050004 (Tm Bioscience Corporation, 2005) after a 448-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it. It has been recalled once.

Decided
Mar 13, 2008
Review
448 days
Class
Class II
Product code
NUA
Recalls
1
Predicates
1

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

Descendants, by year cleared 2009: 1 descendant cleared2010: 1 descendant clearedDEN050004 · Tag-IT Cystic Fibrosis Kit · Tm Bioscience Corporation · 200520052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant 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 deviceK063787 Inplex CF Molecular TestThird Wave Technologies, Inc. · 2008
  3. Descendant · cites it directly · 1 of its ownK090901 Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis…Osmetech Molecular Diagnostics · 2009 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK093974 Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test…Osmetech Molecular Diagnostics · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test…Osmetech Molecular Diagnostics · 2009 · cites it directly1descendant
  • K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN050004Tag-IT Cystic Fibrosis KitTm Bioscience Corporation2005—
0 (this device)K063787Inplex CF Molecular TestThird Wave Technologies, Inc.2008—
+1K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping…Osmetech Molecular Diagnostics20092
+2K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii…Osmetech Molecular Diagnostics2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
FIG. 1 — Lineage of K063787, 2005–2010Source: 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test…Osmetech Molecular Diagnostics20091

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 31, 2016Class IIZ-1580-2016Nonconforming Material/ComponentComplaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K090901 (Osmetech Molecular Diagnostics, 2009) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.

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?

InPlex T CF Molecular Test is an in vitro diagnostic device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human peripheral whole blood specimens. The panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG), plus other more common and North American-prevalent mutations.…

Read the full statement (166 words)

InPlex T CF Molecular Test is an in vitro diagnostic device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human peripheral whole blood specimens. The panel includes mutations and variants recommended by the 2004 American College of Medical Genetics (ACMG), plus other more common and North American-prevalent mutations. The InPlexTM CF Molecular Test is a qualitative genotyping test that provides information intended to be used for cystic fibrosis carrier screening as recommended by ACMG and the 2005 American College of Obstetricians and Gynecologists (ACOG) for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children.

The test is not indicated for use in fetal diagnostic or pre-implantation testing. This test is also not indicated for stand-alone diagnostic purposes and results should be used in conjunction with other available laboratory and clinical information.

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
  • K062028Cystic Fibrosis Genotyping Assay, Model 6L20-01Celera Diagnostics · 2007
  • K060627Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2006
  • K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800Clinical Micro Sensors · 2006

More from Third Wave Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K051824Invader UGT1A1 Molecular AssayThird Wave Technologies, Inc. · 2005

Recent decisions in NUA

The NUA category page

  • 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

https://510kreport.com/device/K063787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063787: Inplex CF Molecular Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063787

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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