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Helena ColoCheck

FDA 510(k)

Class II (US FDA 510(k))

510(k) K800433

by Helena Laboratories

Identifiers

510(k) Number
K800433 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 Helena ColoCheck is a reagent for detecting occult blood, classified as a reagent under the nomenclature for fecal occult blood tests. It is designed to identify hidden blood in stool samples, aiding in the early detection of colorectal abnormalities such as cancer or polyps. The device operates through a chemical reaction that produces a visible color change when blood is present, enabling qualitative assessment of fecal samples.

This reagent is supplied as a single-use diagnostic tool, intended for use in clinical or screening settings by trained personnel. It is not sterile and must be handled in accordance with laboratory protocols. The device is regulated under FDA 510K clearance (K800433) and falls under the classification of Class II medical devices. Storage conditions and expiration dates are specified on the packaging, ensuring proper performance and reliability for its intended use in hematology-based colorectal screening.

Frequently asked questions

What is the Helena ColoCheck used for?

The Helena ColoCheck is a reagent designed to detect occult (hidden) blood in stool samples. It helps identify potential colorectal abnormalities, such as cancer or polyps, by producing a visible color change when blood is present. This qualitative test supports early screening and diagnosis in clinical or screening settings.

Is the Helena ColoCheck sterile?

No, the Helena ColoCheck is not sterile. It is supplied as a single-use diagnostic tool and must be handled according to standard laboratory protocols to ensure proper use and prevent contamination.

How is the Helena ColoCheck supplied?

The Helena ColoCheck is supplied as a single-use reagent kit. Each kit is intended for one-time use in detecting occult blood in fecal samples. The packaging includes storage instructions and expiration dates to maintain the reagent’s reliability.

What are the storage requirements for the Helena ColoCheck?

Storage conditions for the Helena ColoCheck are specified on the packaging. It is important to follow these instructions to preserve the reagent’s performance and accuracy. Typically, this includes protecting it from extreme temperatures, moisture, and direct light until use.

What regulatory pathway does the Helena ColoCheck follow?

The Helena ColoCheck is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K800433. It is classified as a Class II medical device and is intended for use in hematology-based colorectal screening.

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: ColoScreen ES | Helena Laboratories - Innovations for Science ..., Colorectal Screenings | Helena Laboratories - Innovations for Science ..., Helena Laboratories™ ColoScreen™ FOB Test Kit - Fisher Sci

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K800433 24 fields · synced Oct 1, 2026