System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
Medical specialty
Unknown
Device class
3
Review panel
PA
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.