Identity
- Trade Name
- ColoSense® FDA PMA
- Generic Name
- System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection FDA PMA
Identifiers
- PMA Number
- P230001 FDA PMA
- FDA Product Code
- SBB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Pathology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
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, advanced adenomas or serrated precancerous lesions 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 colorectal cancer. The device is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Frequently asked questions
What age group is ColoSense designed for screening, and what does a positive result mean for patients?
ColoSense is intended for adults aged 45 or older who are at average risk for colorectal cancer. A positive result suggests the possible presence of colorectal cancer, advanced adenomas, or serrated precancerous lesions, prompting the need for a follow-up colonoscopy to confirm diagnosis. It is not meant for high-risk individuals as a replacement for diagnostic or surveillance colonoscopy.
How is ColoSense supplied, and is it intended for single-use or reuse?
ColoSense is supplied as a qualitative in vitro diagnostic test kit, though specific packaging details (e.g., test strips, reagents, or sample collection devices) are not provided in the data. Given its classification as a Class III device and its intended use for detecting RNA markers and occult hemoglobin in stool samples, it is designed for **single-use only** per standard IVD practices to ensure accuracy and prevent cross-contamination.
What regulatory pathway was used to approve ColoSense, and what does this mean for its use in clinical settings?
ColoSense was approved through the FDA’s **Premarket Approval (PMA)** process, which is required for Class III devices. This means the device underwent rigorous clinical trials to demonstrate safety and effectiveness before approval. Clinically, this approval confirms its intended use as a screening tool for colorectal neoplasia in average-risk adults aged 45+, but it does not replace colonoscopy for diagnostic or high-risk surveillance purposes.
Does ColoSense detect specific types of colorectal abnormalities, and how does it differ from traditional stool tests?
ColoSense detects **colorectal neoplasia-associated RNA markers** alongside occult hemoglobin in stool, targeting colorectal cancer, advanced adenomas, and serrated precancerous lesions. Unlike traditional stool tests (e.g., FIT) that primarily screen for hemoglobin, ColoSense combines molecular and hemoglobin detection to improve early detection of precancerous and cancerous growths. However, it remains a screening tool—positive results require confirmatory colonoscopy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230001 | Class III | Active |
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Manufacturer
- Manufacturer
- Geneoscopy, Inc.
Sources (1)
- FDA PMA P230001 23 fields · synced Sep 18, 2026