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Quanta Lite Gpa (Gastric Parietal Cell Antibody) Elisa

FDA 510(k)

Class II (US FDA 510(k))

510(k) K010558

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K010558 FDA 510(k)
FDA Product Code
MLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5110 FDA 510(k)
Regulation Number
866.5110 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an enzyme immunoassay for the detection of anti-gastric parietal cell (H+/K+) ATPase IgG antibodies in human serum. It is designed to aid in the diagnosis of conditions associated with elevated levels of these antibodies, including pernicious anemia.

The assay is supplied as reagents for in vitro diagnostic use. It has received FDA 510(k) clearance (K010558) and is classified as a Class II device under regulation number 866.5110. The product is manufactured by Inova Diagnostics, Inc. and is intended for use in clinical laboratory settings.

Frequently asked questions

What is the QUANTA LITE GPA ELISA used for?

The QUANTA LITE GPA ELISA is an enzyme immunoassay designed to detect anti-gastric parietal cell (H+/K+) ATPase IgG antibodies in human serum. It aids in the diagnosis of conditions associated with elevated levels of these antibodies, including pernicious anemia, by providing quantitative or semi-quantitative results for clinical laboratory interpretation.

How is the QUANTA LITE GPA ELISA supplied and what is its intended use setting?

The assay is supplied as reagents for in vitro diagnostic use and is intended for use in clinical laboratory settings. It is not a point-of-care test and requires laboratory equipment and trained personnel to perform the enzyme immunoassay procedure according to the manufacturer's instructions.

Is the QUANTA LITE GPA ELISA a single-use or reusable test system?

The QUANTA LITE GPA ELISA is supplied as reagents for in vitro diagnostic use, which typically includes microplates, controls, conjugates, substrates, and wash buffers. While the microplate may be reused within a single run if properly washed, the reagents are generally intended for single-use per test procedure to ensure accuracy and prevent cross-contamination, as is standard for ELISA kits 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: QUANTA Lite (R) GPA (Gastric Parietal Cell Antibody) Reagents | Werfen ..., QUANTA Lite (R) GPA (Gastric Parietal Cell Antibody) Reagents | Werfen ..., Quanta Lite Gpa (Gastric Parietal Cell Antibody) Elisa (K010558) — Fda ...

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) K010558 24 fields · synced Oct 1, 2026