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ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

by Pillar Biosciences

PMA P200011

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P200011↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP200011 Date30 Jul 2021ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Next generation sequencing oncology panel, somatic or germline variant detection system
PMA Number
FDA Product Code
PQP
Device Class
Class III
Advisory Committee
Medical Genetics
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 ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) is a qualitative next generation sequencing based in vitro diagnostic test that uses amplicon-based target enrichment technology for detection of single nucleotide variants (SNVs) and deletions in 2 genes from DNA isolated from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue specimens. It is intended as a companion diagnostic to identify patients with NSCLC or CRC who may benefit from treatment with targeted therapies listed in the approved therapeutic product labeling.

The O/RDx-LCCA is intended to be used on the Illumina MiSeqDx® instrument. The device is classified as a Next Generation Sequencing Oncology Panel, Somatic or Germline Variant Detection System under FDA PMA authorization (P200011). It is used in clinical laboratory settings for DNA analysis from FFPE tumor specimens and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.

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 specimens does the ONCO/Reveal Dx Lung & Colon Cancer Assay analyze?

    The assay analyzes DNA isolated from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) tumor tissue specimens, as specified in the device's approval documentation.

  • Which instrument is required to run the ONCO/Reveal Dx Lung & Colon Cancer Assay?

    The O/RDx-LCCA is intended to be used on the Illumina MiSeqDx® instrument, as stated in the approval documentation for the device.

  • What genetic variants does the ONCO/Reveal Dx Lung & Colon Cancer Assay detect?

    The assay detects single nucleotide variants (SNVs) and deletions in two genes: KRAS (for colorectal cancer) and EGFR (for non-small cell lung cancer), using amplicon-based target enrichment technology.