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Hemagen ENA Screening Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910232

by Hemagen Diagnostics, Inc.

Identifiers

510(k) Number
K910232 FDA 510(k)
FDA Product Code
LLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Hemagen ENA Screening Kit is an extractable antinuclear antibody, antigen and control device used in immunology testing. It is an enzyme-linked immunosorbent assay that utilizes optical density as a measure of antibody presence, with an established cutoff point between positive and negative reactions.

The device is supplied as a screening kit for in vitro diagnostic use. It is a Class II device cleared by the FDA under 510(k) K910232, with product code LLL. The kit is manufactured by Hemagen Diagnostics, Inc. and is intended for laboratory use only.

Frequently asked questions

What is the Hemagen ENA Screening Kit used for?

It is an enzyme‑linked immunosorbent assay (ELISA) designed to screen for extractable antinuclear antibodies (ENA) in patient samples. The kit provides antigens and controls so laboratories can determine the presence of specific auto‑antibodies by measuring optical density against a defined cutoff.

How is the kit supplied and intended to be used?

The product is provided as a single, ready‑to‑use screening kit for in‑vitro diagnostic (IVD) applications. It is intended for laboratory use only, meaning it must be operated by trained personnel in a clinical or research lab setting and is not for point‑of‑care or bedside testing.

Is the Hemagen ENA Screening Kit a single‑use or reusable product?

The kit is supplied as a disposable, single‑use unit. All reagents, antigens, and controls are packaged for one complete assay run, ensuring consistent performance and preventing cross‑contamination between samples.

What regulatory classification does the kit have?

The Hemagen ENA Screening Kit is classified as a Class II medical device and was cleared by the FDA through the traditional 510(k) pathway (K910232). This classification reflects its moderate risk level and the need for specific regulatory controls.

What storage conditions are recommended for the kit?

While the device data does not list explicit storage parameters, standard practice for ELISA kits is to store them at refrigerated temperatures (2‑8 °C) and protect from light and moisture. Following the manufacturer’s label instructions ensures reagent stability and assay reliability.

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: K952077 - HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | FDA 510 (k), Hemagen Diagnostics, HEMAGEN ENA DSDNA KIT (EIA METHOD) by HEMAGEN DIAGNOSTICS, INC. | FDA ..., K950414 - HEMAGEN ENA SM/RMP KIT (EIA METHOD) | FDA 510 (k), HEMAGEN ENA SCREENING KIT (K910232) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hemagen Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K910232 24 fields · synced Sep 26, 2026