510(k) · Cleared
Recalled · Class II · 2019Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osmetech Molecular Diagnostics · NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Cleared on Jul 6, 2009 as substantially equivalent to K060543 (Clinical Micro Sensors, Inc., 2006) and 3 other predicates after a 96-day review. Its family tree reaches back 3 generations to 2005. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 6, 2009
- Review
- 96 days
- Class
- Class II
- Product code
- NUA
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 3 generations to DEN050004 (2005). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN050004 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005
- 2 generations backK051435 Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna…Clinical Micro Sensors · 2006
- 1 generation backK060543 Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Clinical Micro Sensors, Inc. · 2006
- This deviceK090901 Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis…Osmetech Molecular Diagnostics · 2009
- Descendant · cites it directly · 0 of its ownK093974 Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test…Osmetech Molecular Diagnostics · 2010
Most influential descendants
Showing 1 of 1 · See all- K093974Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii GenotypingOsmetech Molecular Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN050004 | Tag-IT Cystic Fibrosis Kit | Tm Bioscience Corporation | 2005 | — |
| −2 | K051435 | Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection… | Clinical Micro Sensors | 2006 | — |
| −1 | K060543 | Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800 | Clinical Micro Sensors, Inc. | 2006 | — |
| 0 (this device) | K090901 | Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping… | Osmetech Molecular Diagnostics | 2009 | — |
| +1 | K093974 | Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii… | Osmetech Molecular Diagnostics | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
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
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060543 | Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800Summary page 2…an amplified DNA sample utilizing electrochemical detection technology, for use on the eSensor® XT-8 Instrument. Predicate devices: eSensor® CFCD System, K060543 and K051435 InPlex TM CF Molecular Test, K063787 eSensor® XT-8 Instrument, K073720 Device Description: The eSensor® CF Genotypin… | 2006 |
| * | K051435 | Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System…Summary page 2…DNA sample utilizing electrochemical detection technology, for use on the eSensor® XT-8 Instrument. Predicate devices: eSensor® CFCD System, K060543 and K051435 InPlex TM CF Molecular Test, K063787 eSensor® XT-8 Instrument, K073720 Device Description: The eSensor® CF Genotyping Test on th… | 2006 |
| * | K063787 | Inplex CF Molecular TestSummary page 2…detection technology, for use on the eSensor® XT-8 Instrument. Predicate devices: eSensor® CFCD System, K060543 and K051435 InPlex TM CF Molecular Test, K063787 eSensor® XT-8 Instrument, K073720 Device Description: The eSensor® CF Genotyping Test on the eSensor® XT-8 System is an in vitro… | 2008 |
| * | K073720 | Esensor Warfarin Sensitivity and XT-8 InstrumentSummary page 2…the eSensor® XT-8 Instrument. Predicate devices: eSensor® CFCD System, K060543 and K051435 InPlex TM CF Molecular Test, K063787 eSensor® XT-8 Instrument, K073720 Device Description: The eSensor® CF Genotyping Test on the eSensor® XT-8 System is an in vitro diagnostic device for performing… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093974 | Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii Genotyping | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2019 | Class II | Z-2208-2020 | Error in labeling | Incorrect Peel-Apart Introducer Sheath in Kit. |
| Jun 14, 2019 | Class II | Z-2209-2020 | Error in labeling | Incorrect Peel-Apart Introducer Sheath in Kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K093974 (Osmetech Molecular Diagnostics, 2010) has gone furthest, with 0 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. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The eSensor® CF Genotyping 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). The eSensor® CF Genotyping Test is a qualitative…
Read the full statement (172 words)
The eSensor® CF Genotyping 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). The eSensor® CF Genotyping 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.
The eSensor® CF Genotyping Test is intended for use on the eSensor® XT-8 System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090901: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090901
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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