510(k) Report

FDA product code · Pathology

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

PFSClass II21 CFR 866.5900510(k) required1 decision since 20132 recalls

1 FDA decision since 2013. 2 recalls name this code, 0 of them Class I.

The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn…

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

FIG. A — Illustration, pathology panel

Twenty years of PFS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PFS

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

2014: 2
2007high 2 (2014) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20131—00
20140—20
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — PFS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PFS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which PFS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc. · 20133generations

What has FDA decided in PFS lately?

  • K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayIllumina, Inc. · 20132 recalls

The one PFS decision →

What has been recalled in PFS lately?

  • K132750Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0…Illumina Inc · Nov 13, 2014Class II
  • K132750Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system…Illumina Inc · Nov 6, 2014Class III

Related product codes

Other codes under 21 CFR 866.5900.

NUA System, Cystic Fibrosis Transmembrane…PFR System, Cystic Fibrosis Transmembrane…