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Shield

by Guardant Health, Inc. United States PMA

PMA P230009

Product code PHP

Overview

The Shield Test System is a qualitative, in vitro diagnostic device designed to detect colorectal cancer-derived alterations in cell-free DNA from blood samples. Classified as a System for Colorectal Neoplasia Detection via DNA Methylation and Hemoglobin Analysis, it is intended for screening individuals aged 45 or older with average risk of colorectal cancer. Results require follow-up colonoscopy for positive cases, and it is not intended as a replacement for diagnostic or surveillance colonoscopy in high-risk patients.

The Shield Test System is supplied with the Guardant Shield Blood Collection Kit and operates as a single-use diagnostic tool. It is regulated under an FDA Premarket Approval (PMA) and falls under Device Class III. The system is not labeled for MRI compatibility, and no sterility or reuse specifications are provided in the data. Authorized use is restricted to average-risk screening populations as defined in the approved indications.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP230009 Date26 Jul 2024ApprovedStatusActive

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 America
  • Active
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

PMA · synced 22 Oct 2026

Generic Name
System, colorectal neoplasia, DNA methylation and hemoglobin detection
PMA Number
FDA Product Code
PHP
Device Class
Class III
Advisory Committee
Medical Genetics
FDA Decision
APPR Approved

Other devices from Guardant Health, Inc.

Questions

  • What is the Shield Test System designed to detect in blood samples, and who is it intended for?

    The Shield Test System is a qualitative in vitro diagnostic device that detects colorectal cancer-derived alterations in cell-free DNA from blood samples. It is specifically intended for screening individuals aged 45 or older who are at average risk of colorectal cancer. Positive results require follow-up with a colonoscopy, and it is not meant for high-risk patients or as a replacement for diagnostic/surveillance colonoscopy.

  • How is the Shield Test System supplied, and is it reusable?

    The Shield Test System is supplied with the Guardant Shield Blood Collection Kit and is designed as a single-use diagnostic tool. The data does not specify any sterility or reuse specifications, implying it is intended for one-time use per test.

  • What regulatory pathway does the Shield Test System follow, and what class does it belong to?

    The Shield Test System follows the FDA Premarket Approval (PMA) pathway and is classified as a Device Class III. This classification reflects its high-risk nature, requiring rigorous approval before market authorization.

  • Is the Shield Test System compatible with MRI, and what are its intended use restrictions?

    The Shield Test System is explicitly not labeled for MRI compatibility. Its authorized use is restricted to screening individuals at average risk of colorectal cancer, aged 45 or older, and does not apply to high-risk populations or as a substitute for diagnostic/surveillance colonoscopy.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P230009 23 fields · synced 22 Oct 2026