Quanta Lite H-TTG (Human Tissue Transglutaminase) IgG ELISA
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011570 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 H-TTG (Human Tissue Transglutaminase) IgG ELISA is an in vitro diagnostic device used for the qualitative and quantitative detection of IgG antibodies to human tissue transglutaminase in human serum or plasma. This assay is designed to aid in the diagnosis of autoimmune conditions such as celiac disease by measuring the presence of specific autoantibodies.
The device is supplied as a kit containing all necessary components for the enzyme-linked immunosorbent assay procedure. It is intended for professional laboratory use and requires appropriate laboratory equipment and trained personnel. The device is not MRI safe and should be stored as per the manufacturer's instructions. It has received FDA 510(k) clearance with the product code MVM and is classified as Class II medical device.
Frequently asked questions
What is the Quanta Lite H-TTG IgG ELISA used for?
This in vitro diagnostic device is used for the qualitative and quantitative detection of IgG antibodies to human tissue transglutaminase in human serum or plasma, aiding in the diagnosis of autoimmune conditions such as celiac disease.
What components are included in the Quanta Lite H-TTG IgG ELISA kit?
The device is supplied as a complete kit containing all necessary components for performing the enzyme-linked immunosorbent assay procedure, designed for professional laboratory use with appropriate equipment and trained personnel.
Is the Quanta Lite H-TTG IgG ELFDA cleared and what is its classification?
Yes, the device has received FDA 510(k) clearance with the product code MVM and is classified as a Class II medical device, indicating it meets specific safety and effectiveness requirements for its intended use.
How should the Quanta Lite H-TTG IgG ELISA be stored?
The device should be stored according to the manufacturer's instructions, and it is important to note that the device is not MRI safe, requiring appropriate storage conditions to maintain its integrity and performance.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011570 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA 510(k) K011570 24 fields · synced Oct 6, 2026