Autoantibody PROFILE-6 ELISA Test System (LJM)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K933267 FDA 510(k)
- FDA Product Code
- LJM 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 Autoantibody Profile-6 ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human serum. It functions as a semi-quantitative immunoassay to identify specific autoantibodies associated with autoimmune connective tissue disorders, aiding in diagnostic evaluation.
This system is intended for in vitro diagnostic use in clinical laboratories. Supplied as a kit, it includes antigens, controls, and reagents for testing, with no indication of sterility or single-use/reusability in the provided data. The device is classified under FDA regulation 866.5100 and holds a Traditional 510(k) clearance (K933267) from the FDA Immunology (IM) Advisory Committee. No MRI safety or storage specifications are noted in the available records.
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: AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM (K933267) — FDA 510 (k ..., PDF ENA Profile-6 Test System - Zeus Scientific, Inc, PDF K933267 - Autoantibody Profile-6 Elisa Test System, Autoantibody Profile-6 Elisa Test System 510 (k) FDA Premarket ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K933267 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K933267 24 fields · synced Sep 19, 2026