| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | ColoSense® |
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| Generic Name | System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection |
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| Applicant | Geneoscopy, Inc.
2220 Welsch Industrial Court
St. Louis, MO 63146 |
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| PMA Number | P230001 |
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| Date Received | 01/20/2023 |
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| Decision Date | 05/03/2024 |
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| Product Code |
SBB |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT04739722
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
ColoSense is a qualitative in vitro diagnostic test intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA) or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults, 45 years of age or older, who are at average-risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S004 S006 S007 |
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