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Hema-Screen

FDA 510(k)

Class II (US FDA 510(k))

510(k) K902360

by Immunostics Co., Inc.

Identifiers

510(k) Number
K902360 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 Hema-Screen is a reagent designed for the qualitative detection of occult blood in stool samples. Classified as a reagent for occult blood testing, it is intended for use in hematology diagnostics to identify hidden blood that may indicate gastrointestinal conditions.

This device is supplied as a solution reagent kit and is intended for professional use in clinical settings. It is a single-use diagnostic tool, with no specified sterility or MRI safety requirements noted. The product is authorised under FDA 510(k) clearance (K902360) and falls under regulation number 864.6550, categorised under product code KHE. Storage and handling instructions are not provided in the specifications.

Frequently asked questions

What is the primary clinical purpose of the Hema-Screen reagent kit, and how does it function in a lab setting?

The Hema-Screen is designed for the qualitative detection of occult (hidden) blood in stool samples, helping identify potential gastrointestinal conditions. It functions as a reagent kit in clinical hematology labs by reacting with blood in stool to produce a visible indication, allowing professionals to screen for hidden blood that may not be detectable through visual inspection alone.

Is the Hema-Screen intended for single-use or repeated use, and what does this mean for inventory management?

The Hema-Screen is explicitly labeled as a single-use diagnostic tool, meaning each kit is intended for one test cycle only. This design ensures accuracy and hygiene, but it also requires labs to plan inventory accordingly—ordering replacement kits for each new test rather than reusing or reprocessing them.

Does the Hema-Screen come with specific storage instructions, or are there any special handling requirements?

The provided specifications do not include explicit storage or handling instructions for the Hema-Screen reagent kit. Clinicians should follow general best practices for reagent storage (e.g., protecting from extreme temperatures, light exposure, or contamination) until manufacturer guidance is clarified or referenced.

What regulatory pathway was followed for FDA clearance of the Hema-Screen, and how does this affect its use in clinical settings?

The Hema-Screen received FDA 510(k) clearance (K902360) under the *Traditional* review pathway, determined to be *Substantially Equivalent* to a legally marketed predicate device. This clearance confirms its compliance with U.S. regulations for use as a reagent in occult blood testing, ensuring it meets safety and performance standards for professional clinical use in hematology diagnostics.

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: Immunostics Inc | hema - screen, Immunostics Inc | hema - screen, Solution reagent kit - hema-screen™ - Immunostics Inc. - MedicalExpo

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immunostics Co., Inc.

Sources (1)

  • FDA 510(k) K902360 24 fields · synced Sep 19, 2026