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Invitae Common Hereditary Cancers Panel

by Invitae Corporation

De Novo DEN210011

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN210011 Date29 Sep 2023DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
QVU
Device Class
Class II
Regulation
21 CFR Part 866.6095
Advisory Committee
Pathology
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Invitae Common Hereditary Cancers Panel is a high throughput DNA sequencing test system for hereditary cancer predisposition assessment. It analyzes genes associated primarily with adult-onset, nonsyndromic predisposition to cancers of the breast, ovary, uterus, prostate, and gastrointestinal system.

This panel is supplied as a test system and is used for genetic testing purposes. It is authorized under FDA 510K clearance with product code QVU and is regulated for use in pathology. The device is manufactured by Invitae Corporation in San Francisco, California.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Invitae Common Hereditary Cancers Panel used for?

    This is a high throughput DNA sequencing test system designed for assessing hereditary cancer predisposition, primarily focusing on adult-onset, nonsyndromic predisposition to cancers of the breast, ovary, uterus, prostate, and gastrointestinal system.

  • How is the Invitae Common Hereditary Cancers Panel supplied?

    The panel is supplied as a complete test system for genetic testing purposes. It is manufactured by Invitae Corporation in San Francisco, California and is authorized under FDA 510K clearance with product code QVU.

  • What is the regulatory status of the Invitae Common Hereditary Cancers Panel?

    The device is authorized under FDA 510K clearance with product code QVU and is regulated for use in pathology. It received FDA decision on September 29, 2023, with decision code DENG and K-number DEN210011.

  • Is the Invitae Common Hereditary Cancers Panel reusable or single-use?

    The device information does not specify whether the panel is reusable or single-use. As a genetic test system, it is typically designed for single-use testing to ensure accuracy and prevent cross-contamination, but specific usage instructions would be provided by the manufacturer.