Identifiers
- 510(k) Number
- K992759 FDA 510(k)
- FDA Product Code
- KHE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.6550 FDA 510(k)
- Regulation Number
- 864.6550 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Colon Alert Test is a reagent-based diagnostic device classified as an occult blood test. It is designed to detect the presence of hidden blood in stool samples, aiding in the early identification of potential colorectal abnormalities such as polyps or cancer. This in vitro diagnostic tool provides a rapid and sensitive method for screening individuals at risk or undergoing routine health assessments.
The test is supplied as a single-use reagent kit and is intended for use in clinical laboratory settings or home-based screening programs. It requires no special storage conditions beyond standard room temperature and is not intended for reuse. The device is regulated under FDA 510(k) clearance (K992759) and falls under the Hematology advisory committee classification, adhering to regulatory standards for diagnostic reagents. No MRI safety considerations apply, as it is not a medical imaging device.
Frequently asked questions
What is the Colon Alert Test used for?
The Colon Alert Test is a reagent-based diagnostic device designed to detect hidden (occult) blood in stool samples. It helps identify potential colorectal abnormalities, such as polyps or cancer, during early screening. This test is particularly useful for individuals at risk or undergoing routine health assessments, providing a rapid and sensitive method for detection.
How is the Colon Alert Test supplied and intended for use?
The Colon Alert Test is supplied as a single-use reagent kit. It is intended for use in clinical laboratory settings or home-based screening programs. The kit is straightforward to use and does not require specialized equipment beyond standard laboratory or home testing conditions.
Does the Colon Alert Test require special storage conditions?
No, the Colon Alert Test does not require special storage conditions. It can be stored at standard room temperature, making it convenient for both clinical and home use. Always ensure the kit is kept in a dry place and protected from direct sunlight.
Is the Colon Alert Test intended for reuse?
No, the Colon Alert Test is explicitly designed as a single-use reagent kit. Reusing the test could compromise its accuracy and reliability, as it is not sterilized or intended for multiple uses. Each kit should be used once and then discarded.
What regulatory pathway does the Colon Alert Test follow?
The Colon Alert Test is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K992759. It falls under the Hematology advisory committee classification and is classified as a Class II medical device. This regulatory route ensures it meets stringent standards for diagnostic reagents.
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. Sources consulted: COLON ALERT TEST (K992759) — FDA 510 (k) | Innolitics, fda.innolitics.com, PDF K992759 - Colon Alert Test, Colon Alert Test - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992759 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunostics Inc.,
Sources (1)
- FDA 510(k) K992759 24 fields · synced Oct 1, 2026