Skip to content

Therascreen KRAS RGQ PCR Kit

by QIAGEN Manchester, Ltd. PMA

Withdrawn United States

PMA P110030

Overview

The Therascreen KRAS RGQ PCR Kit is a somatic gene mutation detection system designed for the qualitative analysis of human KRAS oncogene mutations. It utilizes real-time PCR technology to detect seven specific somatic mutations using DNA extracted from formalin-fixed paraffin-embedded colorectal cancer tissue.

This assay is intended to be used on the Rotor-Gene Q MDX instrument to aid in the identification of colorectal cancer patients for treatment with Erbitux (cetuximab). The device has received FDA PMA approval for its clinical application in identifying patients based on KRAS mutation status.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Withdrawn since 6 Jul 2012. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP110030 Date6 Jul 2012Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

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

United States — FDA PMA Withdrawn

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
Somatic gene mutation detection system
PMA Number
FDA Product Code
OWD
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APWD Approval withdrawn

Questions

  • What is the primary purpose of the Therascreen KRAS RGQ PCR Kit?

    The kit is a real-time qualitative PCR assay used to detect seven somatic mutations in the human KRAS oncogene from colorectal cancer tissue samples.

  • Which instrument is required to run this assay?

    The Therascreen KRAS RGQ PCR Kit is specifically designed for use on the Rotor-Gene Q MDX instrument.

  • How does this kit assist in clinical decision-making?

    It aids in the identification of colorectal cancer patients for potential treatment with Erbitux (cetuximab) by determining the presence or absence of specific KRAS mutations.