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Nova Lite ANA KSL

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K901596

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K901596 FDA 510(k)
FDA Product Code
DHN 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 Nova Lite ANA KSL is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (per FDA nomenclature). This diagnostic device detects and quantifies antinuclear antibodies (ANA) in serum or plasma samples, aiding in the identification of autoimmune diseases such as systemic lupus erythematosus (SLE) or rheumatoid arthritis. It employs immunofluorescence techniques to visualize antibody binding to cellular substrates, providing qualitative or semi-quantitative results based on fluorescence intensity.

Supplied as a single-use reagent kit, the Nova Lite ANA KSL is intended for use in clinical laboratories under controlled conditions. Sterility is not specified, but it must be handled in accordance with standard laboratory practices for immunoassay controls. The device is classified as Class II under FDA regulations and has received FDA 510K clearance and In Vitro Diagnostic Device Directive (IVDD) authorization. Storage requirements and shelf life are not detailed in the provided data, but compliance with manufacturer instructions is essential for accurate results.

Frequently asked questions

What is the Nova Lite ANA KSL used for in clinical practice?

The Nova Lite ANA KSL is an immunofluorescent control reagent designed to detect and quantify antinuclear antibodies (ANA) in serum or plasma samples. It aids clinicians in diagnosing autoimmune diseases like systemic lupus erythematosus (SLE) or rheumatoid arthritis by visualizing antibody binding through fluorescence intensity, providing qualitative or semi-quantitative results.

Is the Nova Lite ANA KSL intended for single-use, or can it be reused?

The Nova Lite ANA KSL is explicitly supplied as a single-use reagent kit. Since it is a diagnostic control, reuse could compromise accuracy and sterility, so it must be used once per test and then discarded.

How should the Nova Lite ANA KSL be stored, and what are the key handling considerations?

While specific storage requirements and shelf life aren’t detailed in the provided data, the kit must be handled according to standard laboratory practices for immunoassay controls. Compliance with the manufacturer’s instructions is critical to ensure accurate results and prevent contamination or degradation.

What regulatory pathways has the Nova Lite ANA KSL undergone, and what does that mean for its use?

The Nova Lite ANA KSL has received FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD) authorization, confirming it meets regulatory standards for safety and performance. This classification allows its use in clinical laboratories under controlled conditions, ensuring reliability for diagnostic purposes.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K901596 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026