CARE Fecal Occult Blood Test, Model KT313
510(k) K051806
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051806 | Date3 Oct 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KHE
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.6550
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The CARE Fecal Occult Blood Test, Model KT313, is a reagent-based immunological device designed for the qualitative detection of fecal occult blood. Classified as a reagent for occult blood testing, it employs immunochemical methods to identify hidden blood in fecal samples, aiding in the diagnosis of gastrointestinal bleeding associated with conditions such as diverticulitis, colitis, or colorectal disorders.
This test is intended for use in professional laboratories and physician office laboratories. Supplied as a single-use reagent kit, it requires no sterilization beyond manufacturer-provided packaging. The device is regulated under FDA 510(k) clearance (K051806) and falls under the classification of Class II medical devices (regulation number 864.6550). It is not MRI-safe or reusable, and storage conditions are specified by the manufacturer.
From the manufacturer
This EpiTuub® Fecal Occult Blood (FOB) Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories.
Other devices from Epitope Diagnostics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of gastrointestinal conditions can this test help identify through the detection of fecal occult blood?
The CARE Fecal Occult Blood Test, Model KT313, is designed to detect hidden blood in fecal samples, which can aid in diagnosing gastrointestinal bleeding linked to conditions such as diverticulitis, colitis, or colorectal disorders. By identifying occult blood immunochemically, it supports screening for potential underlying issues in the digestive tract.
Is this test reusable, or is it meant for single-use only?
The CARE Fecal Occult Blood Test, Model KT313, is explicitly supplied as a single-use reagent kit. It is not intended for reuse, and no sterilization beyond the manufacturer-provided packaging is required, as it is designed for one-time use per test.
Where should this test be used, and what kind of facilities are authorized to perform it?
This test is intended for use in professional laboratories and physician office laboratories. It is not meant for home use or point-of-care testing outside of these regulated settings, ensuring proper handling and interpretation of results by trained personnel.
How should the test be stored, and are there any special handling instructions?
Storage conditions for the CARE Fecal Occult Blood Test, Model KT313, are specified by the manufacturer, though the exact details are not provided in the data. Generally, reagent-based tests like this should be stored according to the manufacturer’s instructions to maintain integrity, typically in a cool, dry place away from direct sunlight or extreme temperatures.
What regulatory pathway was followed for this device’s approval, and what class does it fall under?
The CARE Fecal Occult Blood Test, Model KT313, was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process, and is classified as a Class II medical device (regulation number 864.6550). This classification indicates it poses moderate risk and requires special controls to ensure safety and effectiveness.