Zeus Anti-Cardiolipin Igs Elisa Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K981020 FDA 510(k)
- FDA Product Code
- MID FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System is an in vitro diagnostic device classified as an immunological test system. It employs enzyme-linked immunosorbent assay (ELISA) technology to detect IgG, IgA, and IgM class autoantibodies to cardiolipin in human serum samples. This assay aids in the identification of antiphospholipid syndrome and related autoimmune conditions by quantifying antibody levels against cardiolipin, a phospholipid commonly associated with these disorders.
This system is intended for use in clinical laboratories and is supplied as a kit containing microwell strips passively adsorbed with cardiolipin antigen. The test is designed for single-use and requires no special handling beyond standard laboratory procedures. It is regulated under FDA 510(k) clearance (K981020) and falls under Class II medical devices, adhering to regulatory standards for in vitro diagnostics. Storage and handling follow manufacturer guidelines to maintain assay integrity.
Frequently asked questions
What is the Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System used for?
This ELISA test system detects and quantifies IgG, IgA, and IgM class autoantibodies to cardiolipin in human serum samples. It helps identify antiphospholipid syndrome and related autoimmune conditions by measuring antibody levels against cardiolipin, a phospholipid linked to these disorders. The results assist clinicians in diagnosing potential autoimmune-related vascular complications.
How is the Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System supplied?
The test system is supplied as a kit containing microwell strips that are pre-coated with cardiolipin antigen. These strips are designed for passive adsorption, enabling the ELISA assay to proceed without additional preparation beyond standard laboratory procedures. The kit includes all necessary reagents for performing the test in a clinical laboratory setting.
Is the Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System single-use or reusable?
The Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System is intended for single-use only. Each microwell strip in the kit is designed to be used once, ensuring accurate and reliable results without cross-contamination or degradation from repeated use. This aligns with standard practices for ELISA-based diagnostic tests to maintain assay integrity.
What regulatory clearance does the Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System hold?
The Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System has received FDA 510(k) clearance under the reference number K981020. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and adheres to regulatory standards for in vitro diagnostics, specifically classified as a Class II medical device.
How should the Zeus Anti-Cardiolipin IgG/IgA/IgM ELISA Test System be stored?
The test system must be stored according to the manufacturer’s guidelines to preserve assay integrity. While specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data, standard practices for ELISA kits typically recommend storing the kit at 2–8°C (refrigerated) and protecting it from light and extreme temperatures. Always refer to the accompanying instructions for precise storage instructions.
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: PDF Cardiolipin IgG Test System - Zeus Scientific, Inc, ZEUS ELISA™ Test Systems - ZEUS Scientific, Zeus Anti-cardiolipin Igs Elisa Test System, Zeus Elisa Cardiolipin Igg/Igm/Iga Test System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981020 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K981020 24 fields · synced Oct 1, 2026