ImmuLisa Enhanced RNA POL III Antibody ELISA
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172078 FDA 510(k)
- FDA Product Code
- NYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ImmuLisa Enhanced RNA POL III Antibody ELISA is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG autoantibodies against RNA polymerase III in human serum. Classified as an anti-ribonucleic acid polymerase (RNAP) III antibody test, it functions as an in vitro diagnostic tool to aid in the identification of anti-RNA POL III IgG antibodies. This assay is intended for use in conjunction with other clinical and laboratory findings to support diagnostic evaluation, particularly in conditions such as scleroderma.
This device is supplied as a single-use in vitro diagnostic reagent kit and requires no special handling beyond standard laboratory protocols. It is classified under FDA product code NYO and falls under Class II – Special Controls with a Traditional 510(k) clearance (K172078). The assay is intended for use in clinical immunology settings and must be stored according to manufacturer instructions to maintain integrity. No MRI safety or sterility claims are specified in the regulatory data.
Frequently asked questions
What clinical conditions is this test primarily used to help diagnose or evaluate?
This test is designed to aid in the identification of IgG autoantibodies against RNA polymerase III, which are associated with certain autoimmune conditions. Specifically, it supports diagnostic evaluation for scleroderma and related connective tissue disorders when used alongside other clinical and laboratory findings. It is not intended as a standalone diagnostic tool but rather as part of a broader immunology assessment.
How is the ImmuLisa Enhanced RNA POL III Antibody ELISA kit supplied, and is it reusable?
The kit is supplied as a single-use in vitro diagnostic reagent kit, meaning each kit is intended for one-time use only. It does not require special handling beyond standard laboratory protocols, so there is no need for sterilization or reuse procedures.
What storage instructions should be followed to ensure the test remains effective?
The test must be stored according to the manufacturer’s instructions to maintain its integrity. While specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data, adherence to the manufacturer’s guidelines—typically found in the kit documentation—is critical to ensure accurate and reliable results.
What regulatory pathway was followed for this device’s clearance, and what committee reviewed it?
The ImmuLisa Enhanced RNA POL III Antibody ELISA received a Traditional 510(k) clearance (K172078) through the FDA’s regulatory pathway, classified under product code NYO as a Class II device with Special Controls. The review was conducted by the Immunology (IM) Advisory Committee, which evaluates devices related to autoantibody testing in clinical immunology.
Is this test suitable for use in any specialized medical imaging environments, such as those involving MRI?
No, this test is not related to medical imaging or MRI safety. It is an in vitro diagnostic reagent kit designed for use in clinical immunology laboratories to detect specific autoantibodies in human serum. MRI safety considerations do not apply, as the device is not implanted or used in imaging procedures.
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: ImmuLisa Enhanced RNA POL III Antibody ELISA (K172078) — FDA 510 (k ..., K172078 FDA 510(k) - ImmuLisa Enhanced RNA POL III Antibody ..., ImmuLisa Enhanced RNA POL III Antibody ELISA - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172078 | Class II | Active |
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Manufacturer
- Manufacturer
- Immco Diagnostics, Inc.
Sources (1)
- FDA 510(k) K172078 24 fields · synced Sep 20, 2026