Immulisa Enhanced Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (ACA) Elisas
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113020 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 Immulisa Enhanced Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (ACA) Elisas are immunological test systems used to detect antibodies against cardiolipin in human serum or plasma. These enzyme-linked immunosorbent assays (ELISAs) are designed to measure IgA, IgG, and IgM class antibodies, including combinations of these isotypes, aiding in the diagnosis of antiphospholipid syndrome and related autoimmune conditions.
The device is supplied as an in vitro diagnostic test kit and is intended for laboratory use only. It is a single-use device and requires appropriate storage conditions as specified by the manufacturer. The Immulisa Enhanced Cardiolipin Elisas have received FDA 510(k) clearance with the product code MID and are classified as Class II medical devices, with authorization number K113020.
Frequently asked questions
What is the purpose of the Immulisa Enhanced Cardiolipin Antibody ELISAS?
These immunological test systems are designed to detect antibodies against cardiolipin in human serum or plasma, aiding in the diagnosis of antiphospholipid syndrome and related autoimmune conditions.
How is the Immulisa Enhanced Cardiolipin Antibody ELISAS supplied?
The device is supplied as an in vitro diagnostic test kit intended for laboratory use only. It is a single-use device that requires appropriate storage conditions as specified by the manufacturer.
What regulatory authorization has the Immulisa Enhanced Cardiolipin Antibody ELISAS received?
The Immulisa Enhanced Cardiolipin Elisas have received FDA 510(k) clearance with the product code MID and are classified as Class II medical devices, with authorization number K113020.
What antibodies do the Immulisa Enhanced Cardiolipin ELISAs detect?
These enzyme-linked immunosorbent assays (ELISAs) measure IgA, IgG, and IgM class antibodies against cardiolipin, including combinations of these isotypes, providing comprehensive testing for antiphospholipid syndrome.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113020 | Class II | Active |
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Manufacturer
- Manufacturer
- Immco Diagnostics, Inc.
Sources (1)
- FDA 510(k) K113020 24 fields · synced Sep 21, 2026