510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132750Substantially Equivalent

Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay

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

K132750 is the FDA 510(k) clearance record for ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY, a class II device, cleared for Illumina, Inc. on under FDA product code PFS (System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection). FDA's definition for product code PFS reads: "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...". FDA records list 6 510(k) clearances for Illumina, Inc., from to . As of , FDA records show 2 recalls naming K132750.

Clearance record

Decision date
Received
(77 days to decision)
Product code
PFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence 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 PFS

Trailing 12 months

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

FDA records show no clearances under product code PFS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFS, 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