510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K124006Substantially Equivalent

Illumina Miseqdx Cystic Fibrosis 139-Variant Assay

Illumina, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K124006 is the FDA 510(k) clearance record for ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY, a class II device, cleared for Illumina, Inc. on under FDA product code PFR (System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection). FDA's definition for product code PFR reads: "The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory...". FDA records list 6 510(k) clearances for Illumina, Inc., from to . As of , FDA records show no recalls naming K124006.

Clearance record

Decision date
Received
(328 days to decision)
Product code
PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
Regulation
21 CFR 866.5900
Device class
Class II
Review panel
Immunology
Applicant
Illumina, Inc. 5200 Illumina Way, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFR

Trailing 12 months

FDA records hold no clearances under product code PFR in the trailing twelve months.

FDA records show no clearances under product code PFR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260