510(k) · Cleared

Cleared

Illumina Miseqdx Cystic Fibrosis 139-Variant Assay

K124006510(k) TraditionalCleared Nov 19, 2013328-day reviewClass II21 CFR 866.5900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Illumina, Inc. · PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

Cleared on Nov 19, 2013 as substantially equivalent to K083845 (Luminex Molecular Diagnostics, Inc., 2009) after a 328-day review. Its family tree reaches back 3 generations to 2005.

Decided: Nov 19, 2013
Review: 328 days
Class: Class II
Product code: PFR
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN050004 (2005). No later device cites it as a predicate yet.

By dateBy generation

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 deviceK124006 Illumina Miseqdx Cystic Fibrosis 139-Variant 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)	K124006	Illumina Miseqdx Cystic Fibrosis 139-Variant Assay	Illumina, Inc.	2013	—

FIG. 1 — Lineage of K124006, 2005–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 PFR? 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

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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	Applicant	Decided	Recalls
*	K083845	Xtag CF60 Kit V2 Summary page 1 …ulator) gene mutation detection (21 CFR 866.5900, Product Code PFR) Predicate Device: Luminex xTAG® Cystic Fibrosis 60 Kit v2 (k083845) Confidential 22 Mlummna…	Luminex Molecular Diagnostics, Inc.	2009	—

Also cleared against K083845: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

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 PFR devices

PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PFR

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PFR

Too few PFR 510(k)s in any year since 2007 to give a median.

Recalls per year · PFR

No recall names PFR since 2007.

Adverse event reports per year · PFR

No MAUDE report names PFR since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (172 words)

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay is a qualitative in vitro diagnostic system used to simultaneously detect 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The variants include those recommended in 2004 by the American College of Medical Genetics (ACMG) and in 2011 by the American College of Obstetricians and Gynecologists (ACOG). The test is intended for carrier screening in adults of reproductive age, in confirmatory diagnostic testing of newborns and children, and as an initial test to aid in the diagnosis of individuals with suspected cystic fibrosis. The results of this test are intended to be interpreted by a board-certified clinical molecular geneticist or equivalent and should be used in conjunction with other available laboratory and clinical information.

This test is not indicated for use for newborn screening, fetal diagnostic testing, pre-implantation testing, or for stand-alone diagnostic purposes.

The test is intended to be used on the Illumina MiSeqDx instrument.

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/K124006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K124006: Illumina Miseqdx Cystic Fibrosis 139-Variant Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124006

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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