EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Cont…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Phadia AB
Identifiers
- 510(k) Number
- K151799 FDA 510(k)
- FDA Product Code
- JZO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5870 FDA 510(k)
- Regulation Number
- 866.5870 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EliA Anti-TG Immunoassay and EliA Anti-TPO Immunoassay are in vitro diagnostic devices designed for the quantitative measurement of thyroid peroxidase (TPO) and thyroglobulin (TG) autoantibodies. These immunoassays utilize the fully automated Phadia FEIA (Fluorescence Enzyme Immunoassay) technology to detect and quantify specific antibodies in serum or plasma samples, aiding in the diagnosis and monitoring of autoimmune thyroid diseases.
These assays are intended for laboratory use on the Phadia 250 or Phadia 2500/5000 systems and are supplied as ready-to-use reagents. The EliA Thyroid Positive Control 250 and EliA Thyroid Positive Control 2500/5000 are included for performance monitoring. The devices are authorized under FDA 510(k) and IVDR regulations, with a classification of Class II (Device Class 2) under FDA regulations. They are not intended for MRI use and are single-use per manufacturer specifications.
Frequently asked questions
What clinical conditions are these immunoassays primarily used to diagnose or monitor?
The EliA Anti-TG and Anti-TPO Immunoassays are designed to quantitatively measure thyroid peroxidase (TPO) and thyroglobulin (TG) autoantibodies in serum or plasma. These assays support the diagnosis and ongoing monitoring of autoimmune thyroid diseases, such as Hashimoto’s thyroiditis and Graves’ disease, by detecting specific antibodies linked to thyroid dysfunction.
Are these assays compatible with any specific laboratory systems, and how are they supplied?
These assays are exclusively intended for use on the Phadia 250 or Phadia 2500/5000 systems, which utilize fully automated Phadia FEIA (Fluorescence Enzyme Immunoassay) technology. They are supplied as ready-to-use reagents, eliminating the need for additional preparation before testing.
What is the sterility and reuse status of these immunoassays, and how should they be stored?
The EliA Anti-TG and Anti-TPO Immunoassays are single-use per manufacturer specifications, meaning each reagent kit is designed for one-time use only. While the data does not specify storage conditions explicitly, typical immunoassay reagents like these are generally stored refrigerated (2–8°C) and protected from light until use, as per standard laboratory practices for sensitive diagnostic assays.
Are there any positive controls included with these assays, and what is their purpose?
Yes, the EliA Thyroid Positive Control 250 (for the Phadia 250 system) and EliA Thyroid Positive Control 2500/5000 (for the Phadia 2500/5000 system) are provided for performance monitoring. These controls help ensure assay accuracy and reliability by validating the testing process, confirming proper calibration, and detecting potential issues with reagents or equipment during routine use.
What regulatory pathways have these devices undergone, and what does that imply for their use?
The EliA assays are authorized under both FDA 510(k) clearance and the EU’s In Vitro Diagnostic Regulation (IVDR), with a classification of Class II (Device Class 2) under FDA guidelines. This implies they meet stringent regulatory standards for safety, performance, and clinical validity, ensuring they can be confidently used in clinical settings for the intended diagnostic purposes. The advisory committee classification (Immunology) further confirms their specialized role in autoimmune testing.
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: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid ..., EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid ..., Laboratory Testing for Autoimmune Thyroid Diseases, Laboratory Testing for Autoimmune Thyroid Diseases
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151799 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (2)
- FDA 510(k) K151799 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026