System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
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Basic Information
- Device Name
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Trade Name
- Cologuard®
- PMA Number
- P130017
- Supplement Number
- S066
- Device Class
- FDA Class 3
- Product Code
- PHP
- Generic Name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 24, 2025
- Date Received
- September 11, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which qualified for review under the Real-Time Review Program. Your supplement requested to modify the in-process sample stability of the hemoglobin sample from 7 days to 14 days at 2 to 8°C, and additional minor labeling changes. Based upon the information submitted, the PMA supplement is approved. You may begin commercial distribution of the device as modified by your PMA supplement in accordance with the conditions described below. Although this letter refers to your product as a device, please be aware that some approved products may instead be combination products.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection | FDA class 3 | Unknown |