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Hemagen Ena Scl-70 Kit (eia Method)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K915282

by Hemagen Diagnostics, Inc.

Identifiers

510(k) Number
K915282 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)

This device is an Extractable Antinuclear Antibody, Antigen And Control, used in immunology for the detection of autoantibodies associated with autoimmune diseases. It is a diagnostic test kit employing the enzyme immunoassay (EIA) method to identify Scl-70 (topoisomerase I) antibodies in patient serum.

The kit is supplied for in vitro diagnostic use in clinical laboratory settings. It is a traditional 510(k) cleared device (K915282) with product code LLL, classified under regulation number 866.5100, and intended for use as specified in its labeling without modification.

Frequently asked questions

What is the HEMAGEN ENA SCL-70 KIT (EIA METHOD) used for?

The kit is used to detect autoantibodies associated with autoimmune diseases, specifically Scl-70 (topoisomerase I) antibodies in patient serum, aiding in the immunology-based diagnosis of conditions such as scleroderma.

How is the HEMAGEN ENA SCL-70 KIT (EIA METHOD) supplied and what method does it use?

The kit is supplied as an in vitro diagnostic test kit for clinical laboratory use and employs the enzyme immunoassay (EIA) method to identify Scl-70 antibodies, utilizing extractable antinuclear antigens and controls as specified in its labeling.

Is the HEMAGEN ENA SCL-70 KIT (EIA METHOD) intended for single-use or reuse?

The device is a traditional 510(k) cleared test kit intended for in vitro diagnostic use as specified in its labeling without modification, indicating it is designed for single-use per test procedure in accordance with standard clinical laboratory practices for reagent kits.

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: K946122 - HEMAGEN ENA SCL-70 KIT (EIA METHOD) | FDA 510 (k), HEMAGEN ENA SCL-70 KIT (EIA METHOD) - Innolitics, HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K915282) - Innolitics, PDF K946122 - Hemagen Ena Scl-70 Kit (Eia Method), HEMAGEN ENA SCL-70 KIT (EIA METHOD) 510(k) K915282 - FDA.report

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) K915282 24 fields · synced Sep 25, 2026