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U.S. Department of Health and Human Services

Product Classification

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Device system, colorectal neoplasia, dna methylation and hemoglobin detection
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.
Physical State The device may be intended for manual or automated assay preparation. It may include specimen collection and preparation kits or reagents, and may utilize an algorithm for result determination.
Technical Method The test uses bisulfite conversion of methylated DNA and polymerase chain reaction to detect methylation of specific DNA markers, and enzymatic detection is used to detect occult hemoglobin.
Target Area human stool, blood, plasma
Review Panel Pathology
Product CodePHP
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible