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MI Cancer Seek

by Caris Life Sciences

PMA P240010

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P240010↗

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 NumberP240010 Date5 Nov 2024ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2521-2025 FDA Class II initiated 17 Jun 2025

    Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

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  • Withdrawn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.

MI Cancer Seek is a next-generation sequencing based in vitro diagnostic device designed for the detection of single nucleotide variants, insertions, and deletions in 228 genes. It also identifies microsatellite instability, tumor mutational burden in patients with solid tumors, and copy number amplification in one gene for breast cancer patients.

This device utilizes total nucleic acid isolated from formalin-fixed paraffin-embedded tumor tissue specimens. It is intended as a companion diagnostic to identify patients who may benefit from specific targeted therapies and provides tumor mutational profiling for use by qualified healthcare professionals in accordance with oncology guidelines.

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 MI Cancer Seek analyze?

    MI Cancer Seek uses total nucleic acid isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens to perform its genomic analysis.

  • What is the primary clinical purpose of this device?

    The device serves as a companion diagnostic to identify patients who may benefit from specific targeted therapies and provides tumor mutational profiling for patients with previously diagnosed solid malignant neoplasms.

  • What genomic markers does MI Cancer Seek detect?

    The panel detects single nucleotide variants, insertions and deletions in 228 genes, microsatellite instability, tumor mutational burden, and copy number amplification in one gene for breast cancer patients.