Shield
FDA premarket approval P230009 · decided 2024-07-26
Approval details
- PMA number
- P230009
- Trade name
- Shield
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Applicant
- Guardant Health, Inc.
- Date received
- 2023-03-10
- Decision date
- 2024-07-26
- Days to decision
- 504 days
- Decision code
- APPR
- Product code
- PHP
- Advisory committee
- Medical Genetics
- Expedited review
- No
- Location
- Palo Alto, CA
- 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.
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