# K051435: Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 Dna Detection System, Model 4800

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Micro Sensors
- Decided: Jan 19, 2006 after 232 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN050004 (2005). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN050004: Tag-IT Cystic Fibrosis Kit, Tm Bioscience Corporation (2005). 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.

## Cited in the summary but kept off the family tree
- K003664: Delfia Neonatal Irt Kit, Model A005-110, Wallac OY (2001). Our reading of the summary gave K003664, FDA’s number for Delfia Neonatal Irt Kit, Model A005-110 (Wallac OY). Its FDA name has none of the distinctive words the summary uses for the device it names, “Affymetrix GeneChip® Microarray Instrumentation System”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K060543: Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800 (2006), 2 descendants of its own
- K090901: Esensor CF Genotyping Testm Esensor System, Esensor Cystic Fibrosis Genotyping Test, Esensor Instrument, Models XT-8 (2009), 1 descendant of its own
- K093974: Esenor Fii-FV-Mthfr Genotyping Test, Esenor Fii-FV Genotyping Test, Esenor Fii Genotyping (2010), 0 descendants of its own

## Indications for use
The eSensor® Cystic Fibrosis Carrier Detection 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 to establish a diagnosis of cystic fibrosis.

Source page: https://510kreport.com/device/K051435
Methodology: https://510kreport.com/methodology