Not Cleared Post-NSE

DEN130018 - CYTOSCAN(R) DX (FDA 510(k) Clearance)

Class II Pathology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN130018 · Affymetrix, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
30d
Days
Class 2
Risk

DEN130018 is an FDA 510(k) submission (not cleared) for the CYTOSCAN(R) DX. Classified as System, Microarray-based, Genome-wide, Postnatal Chromosomal Abnormality Detection (product code PFX), Class II - Special Controls.

Submitted by Affymetrix, Inc. (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on January 17, 2014 after a review of 30 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.5920 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

View all Affymetrix, Inc. devices

Submission Details

510(k) Number DEN130018 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 18, 2013
Decision Date January 17, 2014
Days to Decision 30 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 77d · This submission: 30d
Pathway characteristics

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 Pathology devices follow this clearance model.