# K132750: Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay

- Pathway: 510(k) (Traditional)
- Applicant: Illumina, Inc.
- Decided: Nov 19, 2013 after 77 days
- Product code: PFS (System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083845: Xtag CF60 Kit V2, Luminex Molecular Diagnostics, Inc. (2009) Summary page 2.

## Recalls of this device
- Nov 13, 2014 · Class II · Z-0849-2015: It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or delet
- Nov 6, 2014 · Class III · Z-0850-2015: Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.

## Indications for use
The Illumina MiSeqDx(TM) Cystic Fibrosis Clinical Sequencing Assay is a targeted sequencing in vitro diagnostic system that re-sequences the protein coding regions and intron/exon boundaries of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens collected in K2EDTA. The test detects single nucleotide variants, and small InDels within the region sequenced, and additionally reports on two deep intronic mutations and two large deletions. The test is intended to be used on the Illumina MiSeqDx Instrument. The test is intended to be used as an aid in the diagnosis of individuals with suspected cystic fibrosis (CF). The test is most appropriate when the patient has an atypical or non-classic presentation of CF or when other mutation panels have failed to identify both causative mutations. The results of the test are intended to be interpreted by a board-certified clinical molecular geneticist or equivalent and should be used in conjunction with other available information including clinical symptoms, other diagnostic tests, and family history. This test is not indicated for use for stand-alone diagnostic purposes, fetal diagnostic testing, for pre-implantation testing, carrier screening, newborn screening, or population screening.

Source page: https://510kreport.com/device/K132750
Methodology: https://510kreport.com/methodology