Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: Shield
• Generic Name: System, colorectal neoplasia, DNA methylation and hemoglobin detection
• Applicant: Guardant Health, Inc.; 3000 Hanover St.; Palo Alto, CA 94304
• PMA Number: P230009
• Date Received: 03/10/2023
• Decision Date: 07/26/2024
• Product Code: PHP
• Advisory Committee: Molecular Genetics
• Clinical Trials: NCT04136002
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
The Shield test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit. Shield is intended for colorectal cancer screening in individuals at average risk of the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S011