510(k) DEN130018
DEN130018 is an FDA 510(k) premarket notification submitted by Affymetrix, Inc. for the device "CYTOSCAN(R) DX". The FDA issued a decision of De Novo Granted on January 17, 2014. The device falls under product code PFX (System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection), a Class II device regulated under 21 CFR 866.5920. Affymetrix, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 17, 2014
- Date Received
- December 18, 2013
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection
- Device Class
- Class II
- Regulation Number
- 866.5920
- Review Panel
- PA
- Submission Type
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.