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Antinuclear Antibody (ANA) Test (HEP-2 Cells)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K883883

by Immco Diagnostics, Inc.

Identifiers

510(k) Number
K883883 FDA 510(k)
FDA Product Code
LKJ 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 Antinuclear Antibody (ANA) Test (HEp-2 Cells) is an in vitro diagnostic device intended for the qualitative and semi-quantitative detection of antinuclear antibodies in human serum using indirect immunofluorescence (IIF) on HEp-2 cells. The test utilizes HEp-2 cells, which are human epithelial cells serving as a substrate containing a broad range of nuclear antigens. It provides both a titer and an immunofluorescence pattern to assist in the screening and evaluation of systemic autoimmune rheumatic diseases.

The test is performed in a laboratory setting by trained personnel using serum samples from patients. It is supplied as a diagnostic kit and is intended for single use. The device is regulated under product code LKJ and is authorized through the FDA 510(k) process. Storage conditions and specific reagent handling instructions are defined by the manufacturer, Immco Diagnostics, Inc., and must be followed to ensure test integrity.

Frequently asked questions

What is the ANA Test (HEp-2 Cells) used for?

This test is used to detect antinuclear antibodies in human serum, aiding in the screening and evaluation of systemic autoimmune rheumatic diseases. It provides both a titer and an immunofluorescence pattern.

How is the test supplied and used?

The test is supplied as a diagnostic kit by Immco Diagnostics, Inc. It is intended for single use and must be performed in a laboratory setting by trained personnel using patient serum samples.

What substrate does the test use?

The test utilizes HEp-2 cells, which are human epithelial cells. These cells serve as a substrate containing a broad range of nuclear antigens necessary for detecting various antinuclear antibodies.

What regulatory authorization does this device have?

The device is authorized through the FDA 510(k) process under product code LKJ. It was cleared as substantially equivalent to an existing predicate device.

How should the test be stored and handled?

Storage conditions and specific reagent handling instructions are defined by the manufacturer, Immco Diagnostics, Inc. These must be followed to ensure the integrity and accuracy of the test results.

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: Antinuclear Antibody (ANA) With HEp-2 Substrate by IFA, Anti-Nuclear Antibody Screening Using HEp-2 Cells - PMC, What does an ANA HEp‑2 substrate test result mean, and how should the ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immco Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K883883 24 fields · synced Sep 22, 2026