Not Cleared Direct

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

Class II Medical Genetics device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210011 · Invitae Corporation · Medical Genetics device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
914d
Days
Class 2
Risk

DEN210011 is an FDA 510(k) submission (not cleared) for the Invitae Common Hereditary Cancers Panel. Classified as High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System. (product code QVU), Class II - Special Controls.

Submitted by Invitae Corporation (San Francisco, US). The FDA issued a Not Cleared (DENG) decision on September 29, 2023 after a review of 914 days.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6095 - the FDA medical genetics 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: Regulatory edge-case submission. High predicate equivalence gap. With 914 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Invitae Corporation devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
515d slower than avg
Panel avg: 399d · This submission: 914d
Pathway characteristics

Device Classification

Product Code QVU High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
Device Class Class 2 - 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.
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.