PMA P230009

Device: Shield
Applicant: Guardant Health, Inc.
Product code: PHP
Decision date: 2026-07-22
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Approval order statement: Approval for a change to the Shield EP1 classification model which streamlines Guardant Shield to a methylation-only workflow, removing fragmentomic and somatic components.

Current openFDA PMA Record#

Device: Shield
Applicant: Guardant Health, Inc.
PMA number: P230009
Supplement: S010
Product code: PHP
Generic name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
Decision date: 2026-07-22
Decision code: APPR
Date received: 2025-11-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the Shield EP1 classification model which streamlines Guardant Shield to a methylation-only workflow, removing fragmentomic and somatic components.