510(k) · Cleared
Recalled · Class II · 2014Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Illumina, Inc. · PFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Cleared on Nov 19, 2013 as substantially equivalent to K083845 (Luminex Molecular Diagnostics, Inc., 2009) after a 77-day review. Its family tree reaches back 3 generations to 2005. It has been recalled 2 times.
- Decided
- Nov 19, 2013
- Review
- 77 days
- Class
- Class II
- Product code
- PFS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN050004 (2005). No later device cites it as a predicate yet.
- Root · 3 generations backDEN050004 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2005
- 2 generations backK060627 Tag-IT Cystic Fibrosis KitTm Bioscience Corporation · 2006
- 1 generation backK083845 Xtag CF60 Kit V2Luminex Molecular Diagnostics, Inc. · 2009
- This deviceK132750 Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc. · 2013
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 | K060627 | Tag-IT Cystic Fibrosis Kit | Tm Bioscience Corporation | 2006 | — |
| −1 | K083845 | Xtag CF60 Kit V2 | Luminex Molecular Diagnostics, Inc. | 2009 | — |
| 0 (this device) | K132750 | Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay | Illumina, Inc. | 2013 | — |
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 PFS? 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? (1)
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 |
|---|---|---|---|
| * | K083845 | Xtag CF60 Kit V2Summary page 2…regulatory) gene mutation detection (21 CFR 866.5900, Product Code PFS) Predicate Device: i -TAG Cystic Fibrosis 60 Kit v2 (k083845) Confidential 2 ilium:iha7 MiSeqDx C… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2014 | Class II | Z-0849-2015 | Software design | 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 deletions at specific genomic locations… |
| Nov 6, 2014 | Class III | Z-0850-2015 | Under Investigation by firm | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K083845.
How does its category compare?
All PFS devicesPFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PFS
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · PFS
Too few PFS 510(k)s in any year since 2007 to give a median.
Recalls per year · PFS
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PFS
No MAUDE report names PFS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 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 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…
Read the full statement (193 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132750: Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132750
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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