Cleared Traditional

K062028 - CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 (FDA 510(k) Clearance)

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

K062028 · Celera Diagnostics · Pathology device
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Sep 2007
Decision
416d
Days
Class 2
Risk

K062028 is an FDA 510(k) clearance for the CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01. Classified as System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (product code NUA), Class II - Special Controls.

Submitted by Celera Diagnostics (Alameda, US). The FDA issued a Cleared decision on September 7, 2007 after a review of 416 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

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Submission Details

510(k) Number K062028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2006
Decision Date September 07, 2007
Days to Decision 416 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
339d slower than avg
Panel avg: 77d · This submission: 416d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5900
Definition The Cftr Gene Mutation Detection System Is A Device Used To Simultaneously Detect And Identify A Panel Of Mutations And Variants In The Cftr Gene. It Is Intended As An Aid In Confirmatory Diagnostic Testing Of Individuals With Suspected Cystic Fibrosis (cf), Carrier Identification, And Newborn Screening. This Device Is Not Intended For Stand-alone Diagnostic Purposes, Prenatal Diagnostic, Pre-implantation Or Population 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.