510(k) Report

510(k) · Cleared

Cleared

Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800

K060543510(k) SpecialCleared Mar 28, 200627-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

Clinical Micro Sensors, Inc. · NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Cleared on Mar 28, 2006 as substantially equivalent to K051435 (Clinical Micro Sensors, 2006) after a 27-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it.

Decided
Mar 28, 2006
Review
27 days
Class
Class II
Product code
NUA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations 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 · 2005K051435 · Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800 · Clinical Micro Sensors · 200620052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K051435 · Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800 · Clinical Micro Sensors · 2006DEN050004 · Tag-IT Cystic Fibrosis Kit · Tm Bioscience Corporation · 20050
  1. Root · 2 generations backDEN050004 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005
  2. 1 generation backK051435 Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna…Clinical Micro Sensors · 2006
  3. This deviceK060543 Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 2006
  4. Descendant · cites it directly · 1 of its ownK090901 Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis…Osmetech Molecular Diagnostics · 2009 · Recalled
  5. 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
−2DEN050004Tag-IT Cystic Fibrosis KitTm Bioscience Corporation2005—
−1K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection…Clinical Micro Sensors2006—
0 (this device)K060543Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc.2006—
+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 K060543, 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.

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  • 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
*K051435Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System…
Summary page 1
…Micro Senss, Inc. eSensoit Cystic Fibrosis Carrier Detection Systen Special 530k notification (original 530k ref: k051435) eSensor® Cystic Fibrosis Carrier Detection System 510(k) Summary…
Clinical Micro Sensors2006—

Also cleared against K051435: 1 other device →

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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 8 months on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K090901 (Osmetech Molecular Diagnostics, 2009) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K051435.

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 eSensor® Cystic Fibrosis Carrier Detection (CFCD) System is a device for the detection of carrier status for cystic fibrosis for all adult couples contemplating pregnancy, regardless of ethnicity. It is a qualitative genotyping assay that simultaneously detects mutations currently recommended by the American College of Medical Genetics and American College of Obstetricians and Gynecologists (ACMG/ACOG). The eSensor® CFCD System is not indicated for prenatal screening or for diagnostic purposes, and is for Rx only professional use within the confines of a licensed laboratory, as defined by the Clinical Laboratory Improvement Amendments (CLIA) of 1988.

Indications for use as stated in the FDA summary.

Also cleared against K051435

1 other device cites the same predicate.

  • K090901Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument…Osmetech Molecular Diagnostics · 20092 recalls

More from Clinical Micro Sensors, Inc.

2 FDA decisions under this applicant name. See the company

  • K113731Esensor Respiratory Viral PanelClinical Micro Sensors, Inc. · 2012

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/K060543 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060543: Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060543

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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