Diamedix IS-ANTI-B2 Glycoprotein I IgG/IgM Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013628 FDA 510(k)
- FDA Product Code
- MSV 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 Diamedix IS-Anti-B2 Glycoprotein I IgG/IgM Test System is an indirect enzyme immunoassay (EIA) system for the semi-quantitative detection of IgG and IgM antibodies to B2-glycoprotein I in human serum. It is classified as an immunology diagnostic device and aids in the evaluation of autoimmune thrombotic disorders, particularly in patients with systemic lupus erythematosus (SLE) or SLE-like conditions.
This system is intended for in vitro diagnostic use in clinical laboratories and requires manual or automated processing via compatible systems like the MAGO platform. Supplied as a reagent kit, it includes all necessary components for testing, though sterility and single-use specifications are not explicitly stated in the provided data. The device holds FDA 510(k) clearance (K013628) under the Immunology (IM) advisory committee, adhering to regulatory standards for diagnostic immunoassays.
Frequently asked questions
What clinical conditions is this test system primarily used to evaluate, and how does it help in diagnosis?
This test system is designed for the semi-quantitative detection of IgG and IgM antibodies to B2-glycoprotein I in human serum, aiding in the evaluation of autoimmune thrombotic disorders. It is particularly useful for patients with systemic lupus erythematosus (SLE) or SLE-like conditions, helping clinicians assess potential autoimmune-related thrombotic risks.
Is this test system compatible with automated processing, and if so, which platforms are supported?
Yes, the Diamedix IS-Anti-B2 Glycoprotein I IgG/IgM Test System is intended for use with automated processing systems. It is explicitly stated to be compatible with the MAGO platform, though manual processing is also an option.
How is the test system supplied, and what components are included in the reagent kit?
The test system is supplied as a reagent kit, containing all necessary components required for testing. While the exact contents are not detailed, it is designed for in vitro diagnostic use in clinical laboratories, meaning it is intended for professional use in controlled settings.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its intended use?
The device received FDA clearance through a 510(k) premarket notification process, specifically under the Immunology (IM) advisory committee. The clearance type is traditional, and the device is classified as substantially equivalent to a predicate, meaning it meets regulatory standards for diagnostic immunoassays and is intended for in vitro diagnostic use in clinical laboratories.
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: DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (K013956) — FDA 510(k ..., Diamedix Is-anti-b2 Glycoprotein I Igg/Igm Test System (K013628) — Fda ..., K013956 - Diamedix Is-anti-b2 Glycoprotein I Screen
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013628 | Class II | Active |
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Manufacturer
- Manufacturer
- Diamedix Corp.
Sources (1)
- FDA 510(k) K013628 24 fields · synced Sep 19, 2026