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Signatera CDx

by Natera, Inc.

PMA P260004

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

PMA P260004↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP260004 Date15 May 2026ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
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.

Signatera CDx is a personalized, tumor-informed, multiplex-PCR and next-generation sequencing (NGS)-based assay classified as a Next Generation Sequencing Oncology Panel, Somatic or Germline Variant Detection System. It detects circulating tumor DNA (ctDNA) molecular residual disease (MRD) in plasma derived from peripheral whole blood collected in Streck Cell-Free DNA Blood Collection Tubes (BCTs). The assay uses bespoke panels designed to track somatic variants identified from a patient’s formalin-fixed, paraffin-embedded (FFPE) tumor specimen, enabling targeted monitoring of treatment response.

The device is intended for use in Pathology settings and is supplied as a single-use diagnostic test. It requires sterile handling of blood samples and is not MRI-compatible. Authorized under FDA_PMA (PMA Number: P260004), Signatera CDx is regulated as a Class III device. No additional storage or size specifications are provided beyond the required BCT collection tubes.

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