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Quanta Lite OMP Plus ELISA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081248

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K081248 FDA 510(k)
FDA Product Code
OKM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5785 FDA 510(k)
Regulation Number
866.5785 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Quanta Lite OMP Plus ELISA is an enzyme-linked immunosorbent assay (ELISA) device classified as an Antibodies, Outer-Membrane Proteins diagnostic tool under product code OKM. It is designed to detect human serum IgA antibodies against outer membrane proteins (OMP) in vitro, aiding serological testing for immunologic evaluations in clinical immunology.

This device is intended for use in clinical laboratory settings by trained personnel, requiring human serum samples for analysis. Supplied as a single-use diagnostic kit, it generates semi-quantitative optical density results via an enzyme-linked reaction. The device holds FDA 510(k) clearance (K081248) under the Traditional pathway, adhering to Class II regulatory standards for immunology diagnostics.

Frequently asked questions

What clinical setting is the Quanta Lite OMP Plus ELISA intended for, and who should perform the test?

The Quanta Lite OMP Plus ELISA is designed exclusively for use in clinical laboratory settings by trained personnel, such as laboratory technicians or medical professionals with ELISA experience. It is not intended for point-of-care or in-office testing outside a regulated lab environment. The device requires human serum samples and generates semi-quantitative results via an enzyme-linked immunosorbent assay (ELISA) process.

Is the Quanta Lite OMP Plus ELISA a single-use or reusable device, and how is it supplied?

The Quanta Lite OMP Plus ELISA is supplied as a single-use diagnostic kit, meaning each kit is intended for one test cycle only. It is not designed for reuse or reprocessing. The kit includes all necessary reagents and components for a single ELISA analysis, ensuring consistency and sterility for each use.

What type of results does this device produce, and how are they interpreted?

This device produces semi-quantitative optical density (OD) results through an enzyme-linked reaction, which are measured to detect human serum IgA antibodies against outer membrane proteins (OMP). The results aid in serological testing for immunologic evaluations in clinical immunology, though interpretation requires trained personnel to correlate OD values with clinical context.

How was the regulatory pathway for this device determined, and what does that mean for its use?

The Quanta Lite OMP Plus ELISA was cleared via the FDA 510(k) Traditional pathway under product code OKM (Antibodies, Outer-Membrane Proteins) and classified as a Class II device under regulation number 866.5785. This means it underwent a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and performance standards for immunology diagnostics in clinical laboratories.

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: K081248 - QUANTA LITE OMP PLUS ELISA | FDA 510 (k), QUANTA LITE OMP PLUS ELISA (K081248) — FDA 510(k) | Innolitics, QUANTA LITE OMP PLUS ELISA (K081248) — FDA 510(k) | Innolitics

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) K081248 24 fields · synced Sep 19, 2026