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cobas EGFR Mutation Test v2

by Roche

PMA P120019

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P120019↗

FDA record

Trust

Unverified

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

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP120019 Date14 May 2013ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1320-2015 FDA Class III initiated 13 Jan 2015

    False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Trade Name
Cobas Egfr Mutation Test
Generic Name
Somatic gene mutation detection system
PMA Number
FDA Product Code
OWD
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 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 cobas EGFR Mutation Test v2 is a somatic gene mutation detection system designed for the qualitative detection of specific EGFR gene mutations. It identifies exon 19 deletions and exon 21 (L858R) substitutions in the epidermal growth factor receptor (EGFR) gene from DNA extracted from formalin-fixed paraffin-embedded (FFPE) human non-small cell lung cancer (NSCLC) tumor tissue.

The test is intended to aid in selecting patients with metastatic NSCLC for whom Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor, is indicated. Specimen processing requires the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection. The test is classified as a Class III device under FDA PMA authorization (P120019).

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Questions

AI-generated answers, 18 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 type of mutations does the cobas EGFR Mutation Test v2 detect?

    The test detects exon 19 deletions and exon 21 (L858R) substitution mutations in the EGFR gene, which are specific somatic mutations associated with non-small cell lung cancer.

  • What specimen type is required for the cobas EGFR Mutation Test v2?

    The test requires DNA derived from formalin-fixed paraffin-embedded (FFPE) human non-small cell lung cancer (NSCLC) tumor tissue as the specimen type for analysis.

  • What equipment is needed to perform the cobas EGFR Mutation Test v2?

    The test requires the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection of the target EGFR mutations.