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MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K143483

by Sebia

Identifiers

510(k) Number
K143483 FDA 510(k)
FDA Product Code
CFF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5510 FDA 510(k)
Regulation Number
866.5510 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MINICAP Immunotyping with MINICAP and MINICAP FLEX-PIERCING is an Immunoelectrophoretic device used for the qualitative and quantitative analysis of immunoglobulins (IgG, IgA, IgM). It employs immunoelectrophoresis techniques to detect and classify serum protein patterns, aiding in the diagnosis and monitoring of immunologic disorders, including primary immunodeficiencies and monoclonal gammopathies.

This system is supplied as a disposable, single-use kit and is intended for use in clinical laboratories under controlled conditions. The MINICAP FLEX-PIERCING system ensures precise sample application, while the MINICAP platform provides automated processing and analysis. Authorized under FDA 510(k) clearance (K143483) and IVDR compliance, it adheres to regulatory standards for immunology diagnostics, with no MRI safety restrictions. Storage requires refrigeration (2–8°C) and protection from light.

Frequently asked questions

What types of immunologic disorders can the MINICAP Immunotyping system help diagnose or monitor?

The MINICAP Immunotyping system is designed for the qualitative and quantitative analysis of immunoglobulins (IgG, IgA, IgM) using immunoelectrophoresis. It aids in diagnosing and monitoring immunologic disorders such as primary immunodeficiencies and monoclonal gammopathies by detecting and classifying serum protein patterns.

Is the MINICAP system reusable, or is it meant for single-use only?

The MINICAP Immunotyping system is supplied as a disposable, single-use kit. This ensures consistency in results and reduces the risk of cross-contamination, which is critical for accurate immunotyping analysis in clinical laboratories.

How should the MINICAP Immunotyping system be stored, and what are the key storage requirements?

The MINICAP system requires refrigeration between 2–8°C and must be protected from light. Proper storage conditions are essential to maintain the integrity and performance of the disposable components, ensuring reliable results when used.

What regulatory pathways has the MINICAP Immunotyping system undergone, and what does this mean for its use?

The MINICAP Immunotyping system has been authorized through FDA 510(k) clearance (K143483) and is compliant with the In Vitro Diagnostic Regulation (IVDR). This means it meets regulatory standards for safety and performance, allowing its use in clinical laboratories under controlled conditions for immunotyping analysis.

Does the MINICAP system include any automated features, and if so, how do they improve workflow?

Yes, the MINICAP platform provides automated processing and analysis, which streamlines workflow by reducing manual handling. The MINICAP FLEX-PIERCING system also ensures precise sample application, enhancing accuracy and efficiency in immunoelectrophoretic testing.

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 (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sebia

Sources (2)

  • FDA 510(k) K143483 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026