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FoundationOne Liquid CDx

by Foundation Medicine, Inc. PMA

Active United States

PMA P200016

Overview

FoundationOne Liquid CDx is a qualitative next-generation sequencing (NGS) in vitro diagnostic test designed for targeted high-throughput hybridization-based capture. It detects and reports substitutions, insertions, deletions (indels), rearrangements in four genes, and copy number alterations in three genes across 311 genes. The assay utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anticoagulated peripheral whole blood, enabling genomic profiling of cancer patients without requiring fresh tissue samples.

The test is performed as a single-site assay at Foundation Medicine, Inc. in Cambridge, MA, and is supplied with FoundationOne Liquid CDx cfDNA blood collection tubes as part of the Blood Sample Collection Kit. It is intended for use as a companion diagnostic to identify patients eligible for specific targeted therapies, as outlined in the approved therapeutic product labeling. The device operates under FDA PMA authorization (P200016) and is classified as a Class III medical device (OpenFDA: PQP).

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPCB NumberP200016 Date6 Nov 2020DecidedStatusActive

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 Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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
APCB

Other devices from Foundation Medicine, Inc.