# K090901: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8

- Pathway: 510(k) (Traditional)
- Applicant: Osmetech Molecular Diagnostics
- Decided: Jul 6, 2009 after 96 days
- Product code: NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection)
- Device class: 2
- Regulation: 21 CFR 866.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN050004 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060543: Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800, Clinical Micro Sensors, Inc. (2006) Summary page 2.
- K051435: Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800, Clinical Micro Sensors (2006) Summary page 2.
- K063787: Inplex CF Molecular Test, Third Wave Technologies, Inc. (2008) Summary page 2.
- K073720: Esensor Warfarin Sensitivity and XT-8 Instrument, Osmetech Molecular Diagnostics (2008) Summary page 2.

## Most influential descendants
- K093974: Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii Genotyping (2010), 0 descendants of its own

## Recalls of this device
- Jun 14, 2019 · Class II · Z-2208-2020: Incorrect Peel-Apart Introducer Sheath in Kit.
- Jun 14, 2019 · Class II · Z-2209-2020: Incorrect Peel-Apart Introducer Sheath in Kit.

## Indications for use
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.

Source page: https://510kreport.com/device/K090901
Methodology: https://510kreport.com/methodology