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Quanta Lite F-Actin Iga Elisa

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072967

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K072967 FDA 510(k)
FDA Product Code
MVM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5660 FDA 510(k)
Regulation Number
866.5660 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The QUANTA Lite F-actin IgA Assay is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA antibodies to F-actin component of smooth muscle in human serum. It is classified as an Autoantibodies, Endomysial (Tissue Transglutaminase) device under the Immunology medical specialty.

The device is a Class 2 Immunology device with product code MVM, cleared through the FDA Traditional 510(k) pathway under K072967. It is supplied as a single unit per EA (each) and is intended for use in laboratory settings for the detection of autoantibodies in human serum.

Frequently asked questions

What is the QUANTA Lite F-actin IgA ELISA used for?

The QUANTA Lite F-actin IgA ELISA is used for the semi-quantitative detection of IgA antibodies to the F-actin component of smooth muscle in human serum, aiding in the assessment of autoantibodies associated with autoimmune conditions.

How is the QUANTA Lite F-actin IgA ELISA supplied and intended for use?

The device is supplied as a single unit per EA (each) and is intended for use in laboratory settings to detect autoantibodies in human serum samples via an enzyme-linked immunosorbent assay (ELISA) format.

What regulatory pathway was used for the QUANTA Lite F-actin IgA ELISA?

The QUANTA Lite F-actin IgA ELISA was cleared through the FDA Traditional 510(k) pathway under submission number K072967, demonstrating substantial equivalence to a legally marketed predicate device.

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: PDF Microsoft Word - k072967-mmc.doc - Food and Drug Administration, K072967 FDA 510 (k) - QUANTA LITE F-ACTIN IGA ELISA, QUANTA Lite | Werfen North America, QUANTA Lite F Actin IgA ELISA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K072967 24 fields · synced Sep 25, 2026