Cleared Traditional

K163367 - GenetiSure Dx Postnatal Assay (FDA 510(k) Clearance)

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

K163367 · Agilent Technologies, Inc. · Medical Genetics device
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Aug 2017
Decision
254d
Days
Class 2
Risk

K163367 is an FDA 510(k) clearance for the GenetiSure Dx Postnatal Assay. Classified as System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection (product code PFX), Class II - Special Controls.

Submitted by Agilent Technologies, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 11, 2017 after a review of 254 days - an extended review cycle.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.5920 - the FDA medical genetics 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Medical Genetics review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K163367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2016
Decision Date August 11, 2017
Days to Decision 254 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d faster than avg
Panel avg: 399d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PFX System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5920
Definition A Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection System Is Used To Qualitatively Detect Constitutional Gains And Losses In Chromosomal Copy Numbers Across The Human Genome Using Microarray Methods. It Is Intended As An Aid In The Postnatal Diagnosis Of Developmental Delay And/or Intellectual Disability (dd/id), Congenital Anomalies, And Dysmorphic Features In Conjunction With Other Clinical Information Currently Used In Postnatal Diagnosis. It Is Not Intended To Be Used For Standalone Diagnostic Purposes, Prenatal Or Pre-implantation Testing Or Screening, Population Screening, Or For The Detection Of, Or Screening For, Acquired Or Somatic Genetic Aberrations.
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 Medical Genetics devices follow this clearance model.