SBB — System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection Class III
FDA product code SBB covers "System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SBB
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Unknown
- Implant
- No
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.