PMA P230001S005

Device: ColoSense
Applicant: Geneoscopy, Inc.
PMA number: P230001
Supplement: S005
Product code: SBB
Decision date: 2025-05-14
Classification: Pathology
Generic name: System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
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.

Current openFDA PMA Record#

Device: ColoSense
Applicant: Geneoscopy, Inc.
PMA number: P230001
Supplement: S005
Product code: SBB
Generic name: System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection
Decision date: 2025-05-14
Decision code: APPR
Date received: 2024-08-23
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.