System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
A colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic test intended to detect colorectal neoplasia-associated RNA markers and occult hemoglobin in human stool to aid in the detection of colorectal cancer and advanced adenomas in average-risk adults aged 45 and older; a positive result should be followed by diagnostic colonoscopy. It is classified as FDA Class III (PMA required) due to its high-risk nature as a cancer screening tool, reviewed by the Pathology panel with product code SBB and no assigned regulation number. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SBB
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- PA
- Submission Type
- 2
Device Characteristics
Definition
The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.