Cleared Traditional

K132750 - ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132750 · Illumina, Inc. · Pathology device
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Nov 2013
Decision
77d
Days
Class 2
Risk

K132750 is an FDA 510(k) clearance for the ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY. Classified as System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection (product code PFS), Class II - Special Controls.

Submitted by Illumina, Inc. (San Diego, US). The FDA issued a Cleared decision on November 19, 2013 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5900 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Illumina, Inc. devices

Submission Details

510(k) Number K132750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date November 19, 2013
Days to Decision 77 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 77d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5900
Definition 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, Population, Or Pre-implantation), Prenatal Diagnostic, Or Used For Stand-alone Diagnostic Purposes
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.