Cleared Traditional

K124006 - ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (FDA 510(k) Clearance)

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

K124006 · Illumina, Inc. · Pathology device
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Nov 2013
Decision
328d
Days
Class 2
Risk

K124006 is an FDA 510(k) clearance for the ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY. Classified as System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection (product code PFR), 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 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K124006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date November 19, 2013
Days to Decision 328 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
251d slower than avg
Panel avg: 77d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5900
Definition 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 Diagnostic Testing Of Individuals With Suspected Cystic Fibrosis (cf), And As An Initial Test To Aid In The Diagnosis Of Individuals With Suspected Cf. It Is Not Intended For Stand-alone Diagnostic Purposes, Prenatal Diagnostic, Or Pre-implantation Screening.
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.