Not Cleared Direct

DEN210011 - Invitae Common Hereditary Cancers Panel (FDA 510(k) Clearance)

DEN210011 · Invitae Corporation · Medical Genetics device
Sep 2023
Decision
914d
Days
Class 2
Risk

DEN210011 is an FDA 510(k) submission for the Invitae Common Hereditary Cancers Panel. This device is classified as a High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System. (Class II - Special Controls, product code QVU).

Submitted by Invitae Corporation (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on September 29, 2023.

This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.6095. A High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System Is A Qualitative In Vitro Diagnostic (ivd) System Intended For Analysis Of Human Dna Extracted From Human Specimens To Detect Germline Mutations In A Panel Of Targeted Cancer Related Genes. It Is Intended To Aid In Hereditary Cancer Predisposition Assessment By Qualified Health Care Professionals In Accordance With Professional Guidelines. The Device Is Not Intended For Screening, Prenatal Testing Or As A Stand-alone Diagnostic Test. The Device Is For Prescription Use Only..

Submission Details

510(k) Number DEN210011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 29, 2021
Decision Date September 29, 2023
Days to Decision 914 days
Submission Type Direct
Review Panel Medical Genetics (MG)
Summary -

Device Classification

Product Code QVU - High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.6095
Definition A High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System Is A Qualitative In Vitro Diagnostic (ivd) System Intended For Analysis Of Human Dna Extracted From Human Specimens To Detect Germline Mutations In A Panel Of Targeted Cancer Related Genes. It Is Intended To Aid In Hereditary Cancer Predisposition Assessment By Qualified Health Care Professionals In Accordance With Professional Guidelines. The Device Is Not Intended For Screening, Prenatal Testing Or As A Stand-alone Diagnostic Test. The Device Is For Prescription Use Only.