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Quanta Lite RNP ELISA

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K922833

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K922833 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 Quanta Lite RNP ELISA is an Extractable Antinuclear Antibody, Antigen and Control for in vitro diagnostic use, designed for the semi-quantitative detection of anti-RNP (U1 ribonucleoprotein) antibodies in human serum. It falls under the classification of a microwell plate-based enzyme-linked immunosorbent assay (ELISA), enabling laboratory testing for autoimmune conditions associated with antinuclear antibody presence, such as systemic lupus erythematosus or mixed connective tissue disease.

This device is supplied as a kit containing a microwell plate (12 × 8 wells), prediluted controls (negative, low positive, high positive), sample diluent, wash concentrate, HRP-conjugated goat anti-human IgG, and TMB substrate. It is intended for single-use in vitro diagnostic testing and requires no special regulatory considerations beyond its FDA 510(k) clearance (K922833) and In Vitro Diagnostic Device Directive (IVDD) compliance. Storage and handling follow standard ELISA protocols, with components stored refrigerated until use.

Frequently asked questions

What types of autoimmune conditions can this test help identify, and how does it work?

The Quanta Lite RNP ELISA is designed to detect anti-RNP (U1 ribonucleoprotein) antibodies in human serum, which are associated with autoimmune conditions like systemic lupus erythematosus (SLE) and mixed connective tissue disease. It functions as a microwell plate-based ELISA, allowing laboratories to perform semi-quantitative testing for these antibodies through a standardized immunoassay process.

Is this device single-use, and if so, what does the kit include for testing?

Yes, the Quanta Lite RNP ELISA is intended for single-use only. The kit includes a microwell plate (12 × 8 wells), prediluted controls (negative, low positive, high positive), sample diluent, wash concentrate, HRP-conjugated goat anti-human IgG, and TMB substrate—all essential components for performing the ELISA test in a laboratory setting.

How should the components of this kit be stored before use?

The components of the Quanta Lite RNP ELISA kit should be stored refrigerated until use, following standard ELISA protocols. This ensures the stability and integrity of the reagents for accurate testing results.

What regulatory pathways does this device follow, and how does that affect its use?

The Quanta Lite RNP ELISA is cleared via the FDA’s 510(k) pathway (K922833) and complies with the In Vitro Diagnostic Device Directive (IVDD). This means it has undergone regulatory review for safety and performance, allowing laboratories to use it confidently for diagnostic testing without additional regulatory hurdles beyond standard IVD handling.

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: INOVA DIAGNOSTICS, INC. 708565 QUANTA Lite® RNP ELISA, QUANTA Lite | Werfen North America, QUANTA LITE RNP ELISA (K922833) — FDA 510 (k) | Innolitics, AccessGUDID - DEVICE: QUANTA Lite® RNP ELISA (08426950456155)

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) K922833 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026