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Anti-ENA Antibody Test (SM)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920385

by Immco Diagnostics, Inc.

Identifiers

510(k) Number
K920385 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 Anti-ENA Antibody Test (SM) is an in vitro diagnostic device classified as an Extractable Antinuclear Antibody, Antigen, and Control. It is designed to detect and measure antibodies against extractable nuclear antigens (ENA), which are associated with autoimmune diseases such as systemic lupus erythematosus, scleroderma, and mixed connective tissue disease.

This test is intended for use in clinical laboratories under CLIA regulations and is supplied as a reagent kit for serological testing. It is classified as a Class II device under FDA regulation 866.5100 and has received a 510(k) clearance (K920385) as substantially equivalent. The device is not described as single-use or reusable, nor is MRI safety or sterility explicitly mentioned in the provided data.

Frequently asked questions

What autoimmune diseases is the Anti-ENA Antibody Test (SM) designed to help diagnose?

This test detects antibodies against extractable nuclear antigens (ENA), which are associated with autoimmune conditions such as systemic lupus erythematosus (SLE), scleroderma, and mixed connective tissue disease. By identifying these antibodies, clinicians can better assess potential autoimmune disorders in patients.

How is the Anti-ENA Antibody Test (SM) supplied, and where is it intended for use?

The test is supplied as a reagent kit specifically for serological testing in clinical laboratories. It must be used in facilities certified under the Clinical Laboratory Improvement Amendments (CLIA) regulations to ensure accurate and reliable diagnostic results.

Is the Anti-ENA Antibody Test (SM) single-use or reusable?

The provided data does not specify whether the test components are single-use or reusable. However, reagent kits like this are typically designed for single-use per test to maintain accuracy and prevent cross-contamination, though verification with manufacturer guidelines is recommended.

What regulatory pathway does the Anti-ENA Antibody Test (SM) follow?

The device is classified as a Class II medical device under FDA regulation 866.5100 and has received a 510(k) clearance (K920385) as substantially equivalent to a predicate device. This clearance confirms its compliance with FDA standards for safety and effectiveness in detecting ENA antibodies.

What type of laboratory staff should perform this test?

This test is intended for use in clinical laboratories by trained personnel, such as medical technologists or laboratory scientists, who are experienced in serological testing and CLIA-compliant procedures. Proper training ensures accurate interpretation of results for diagnosing autoimmune-related conditions.

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: IMMCO Diagnostics Anti-ENA Antibody Test Diagnostic Test | NextWaveMD, ANTI-ENA ANTIBODY TEST (SM) 510 (k) K920385 - FDA.report, Immco Diagnostics | Immco Diagnostics

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) K920385 24 fields · synced Oct 1, 2026