Identifiers
- 510(k) Number
- K250408 FDA 510(k)
- FDA Product Code
- LLL 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 Alegria Flash ENA Screen is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to Jo-1, SSA-52, SSA-60, SS-B, Scl-70, Sm, or SmRNP in human serum. It is a blood test that detects autoantibodies, which are antibodies the body mistakenly makes against its own cellular machinery, indicating potential autoimmune connective tissue disease.
The device is manufactured by Zeus Scientific and is authorized under FDA 510(k) with K number K250408. It is intended for use in immunology testing and is supplied as a kit for laboratory use. The device is not described as single-use or reusable, and no information regarding MRI safety, sterility, or storage conditions is provided.
Frequently asked questions
What is the Alegria Flash ENA Screen used for?
The Alegria Flash ENA Screen is a blood test that detects IgG autoantibodies to Jo-1, SSA-52, SSA-60, SS-B, Scl-70, Sm, or SmRNP in human serum, which can indicate potential autoimmune connective tissue disease.
How is the Alegria Flash ENA Screen supplied?
The device is supplied as a kit for laboratory use, manufactured by Zeus Scientific, and is intended for immunology testing purposes in clinical laboratory settings.
What is the regulatory status of the Alegria Flash ENA Screen?
The Alegria Flash ENA Screen is authorized under FDA 510(k) with K number K250408, classified as substantially equivalent to predicate devices for extractable antinuclear antibody, antigen and control testing.
Is the Alegria Flash ENA Screen single-use or reusable?
The device is not described as single-use or reusable in the provided information, so specific details about its intended use frequency are not available.
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: Alegria Flash ENA Screen - BioCosm, Alegria Flash ENA Screen (K250408) — FDA 510 (k) | Innolitics, Alegria Flash - zeusscientific.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250408 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific
Sources (1)
- FDA 510(k) K250408 24 fields · synced Sep 26, 2026