Identifiers
- 510(k) Number
- K011415 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 Milenia Anti-Tg EIA is an enzyme-linked immunosorbent assay (EIA) designed for the qualitative detection of thyroid peroxidase (Tg) autoantibodies in human serum or plasma. As a diagnostic test, it falls under the category of a system for testing thyroid autoantibodies, specifically targeting autoimmune thyroid disease markers. This immunoassay quantifies the presence of anti-thyroglobulin antibodies, aiding in the diagnosis of Hashimoto’s thyroiditis and other autoimmune thyroid conditions.
This device is intended for in vitro diagnostic use in clinical laboratories and is supplied as a single-use kit. It requires no special storage conditions beyond refrigeration at 2–8°C and is not intended for MRI environments. The assay is cleared by the FDA under 510(k) classification, with a product code of JZO, and is classified as a Class II medical device under regulation 866.5870. It is not reusable and must be handled according to standard laboratory protocols for immunoassays.
Frequently asked questions
What is the Milenia Anti-Tg EIA used for?
The Milenia Anti-Tg EIA is an enzyme-linked immunosorbent assay (EIA) designed for the qualitative detection of thyroid peroxidase (Tg) autoantibodies in human serum or plasma. It helps diagnose autoimmune thyroid diseases, such as Hashimoto’s thyroiditis, by identifying the presence of anti-thyroglobulin antibodies. This test is specifically categorized under systems for testing thyroid autoantibodies and is intended for in vitro diagnostic use in clinical laboratories.
How is the Milenia Anti-Tg EIA supplied, and is it reusable?
The Milenia Anti-Tg EIA is supplied as a single-use kit, meaning each kit is intended for one-time use only. This design ensures consistency and reliability in test results while minimizing the risk of cross-contamination. Reuse is not recommended or applicable for this device.
What storage conditions are required for the Milenia Anti-Tg EIA?
The Milenia Anti-Tg EIA requires standard refrigeration storage at temperatures between 2–8°C. No additional specialized storage conditions are necessary, but it should be kept in its original packaging until use. Avoid exposure to temperatures outside this range, as it may compromise the assay’s performance.
Can the Milenia Anti-Tg EIA be used in an MRI environment?
No, the Milenia Anti-Tg EIA is not intended for use in MRI environments. The device is designed exclusively for in vitro diagnostic use in clinical laboratories and does not contain components or materials that would be compatible with MRI settings. Always follow the manufacturer’s instructions for proper handling and usage.
What regulatory pathway does the Milenia Anti-Tg EIA follow?
The Milenia Anti-Tg EIA is cleared by the FDA under the 510(k) pathway, specifically classified as a Class II medical device under regulation 866.5870. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device. The product code assigned is JZO, reflecting its classification as a system for testing thyroid autoantibodies.
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: ALPCO MILENIA ANTI-TG EIA (K011415) — FDA 510(k) | Innolitics, American Laboratory Products Co., Ltd. - FDA 510 (k) Cleared Devices, AMERICAN LABORATORY PRODUCTS CO., LTD. - fda.report, ALPCO Life Science/Clinical Research & Diagnostic Products, All Products | Research Assays, ELISA Kits & Diagnostic Solutions | ALPCO
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011415 | Class II | Active |
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Manufacturer
- Manufacturer
- American Laboratory Products Co., Ltd.
Sources (1)
- FDA 510(k) K011415 24 fields · synced Oct 1, 2026