PHP · System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
· Class 3
Overview
| Product Code | PHP |
|---|---|
| Device Name | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection |
| Device Class | Class 3 |
| Review Panel |
Identification
The colorectal neoplasia DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230043 | Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus | Exact Sciences Corporation | Oct 3, 2024 | APPR |
| P230009 | Shield | Guardant Health, Inc. | Jul 26, 2024 | APPR |
| P130001 | Epi proColon | New Day Diagnostics, LLC | Apr 12, 2016 | APPR |
| P130017 | COLOGUARD | Exact Sciences Corporation | Aug 11, 2014 | APPR |
Top Applicants
- Exact Sciences Corporation — 2 clearances
- Guardant Health, Inc. — 1 clearance
- New Day Diagnostics, LLC — 1 clearance
