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Quanta Lite B2gpi Igg

FDA 510(k)

Class II (US FDA 510(k))

510(k) K970551

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K970551 FDA 510(k)
FDA Product Code
MSV 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 B2GPI IGG is a system for the semi-quantitative detection of autoantibodies in human serum. This test is designed to identify antibodies against B2-Glycoprotein I (B2-GPI) and is part of the QUANTA Lite family of reagents.

The device is supplied by Inova Diagnostics, Inc. and is classified under product code MSV with a device class of 2. It received FDA 510(k) clearance on June 24, 1997, with the K number K970551, and is regulated under number 866.5660. The device is intended for use in immunology testing.

Frequently asked questions

What is the QUANTA LITE B2GPI IGG system used for?

The QUANTA LITE B2GPI IGG is a system for the semi-quantitative detection of autoantibodies in human serum, specifically designed to identify antibodies against B2-Glycoprotein I (B2-GPI). It is part of the QUANTA Lite family of reagents and intended for immunology testing.

How is the QUANTA LITE B2GPI IGG supplied?

The device is supplied by Inova Diagnostics, Inc. and is classified under product code MSV with a device class of 2. It is supplied as part of the QUANTA Lite family of reagents for laboratory use in immunology testing.

What is the regulatory status of the QUANTA LITE B2GPI IGG?

The device received FDA 510(k) clearance on June 24, 1997, with the K number K970551, and is regulated under number 866.5660. It is classified as substantially equivalent and intended for use in immunology testing.

Is the QUANTA LITE B2GPI IGG a single-use or reusable device?

The device is supplied as a test system for laboratory use. The description does not specify whether individual components are single-use or reusable, as this is a laboratory test system rather than a patient-facing 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: QUANTA LITE B2GPI IGG (K970551) — FDA 510 (k) | Innolitics, K970551 FDA 510 (k) - QUANTA LITE B2GPI IGG, QUANTA Lite | Werfen North America, QUANTA LITE B2GPI IGG 510 (k) K970551 - FDA.report, INOVA DIAGNOSTICS, INC. 708665.10L QUANTA LITE® B2 GPI IgG ELISA Bulk ...

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) K970551 24 fields · synced Sep 28, 2026