# K063787: Inplex CF Molecular Test

- Pathway: 510(k) (Traditional)
- Applicant: Third Wave Technologies, Inc.
- Decided: Mar 13, 2008 after 448 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: 1 (0 Class I)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- 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

## Recalls of this device
- Mar 31, 2016 · Class II · Z-1580-2016: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

## Indications for use
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.

Source page: https://510kreport.com/device/K063787
Methodology: https://510kreport.com/methodology