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Aptiva APS IgG Reagent - Aptiva APS IgM Reagent

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223093

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K223093 FDA 510(k)
FDA Product Code
MID FDA 510(k)
Models / Variants
Aptiva APS IgG Reagent FDA 510(k)EUDAMED
Aptiva APS IgM Reagent FDA 510(k)EUDAMED

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 Aptiva APS IgG and IgM Reagents are in vitro diagnostic tests designed for the immunological detection of anticardiolipin antibodies (IgG and IgM isotypes) in human serum or plasma. These reagents are classified as immunological test systems and are used to aid in the diagnosis of antiphospholipid syndrome and related autoimmune conditions by quantifying antibody levels against cardiolipin.

These reagents are supplied as ready-to-use components for automated immunoassay systems and are intended for single-use only. They are authorized under FDA 510(k) clearance and comply with the In Vitro Diagnostic Regulation (IVDR). Storage requires refrigeration between 2°C and 8°C, and the reagents must remain protected from light. No MRI safety information is specified, and the devices are classified as Class II under FDA regulations.

Frequently asked questions

What clinical conditions are these reagents primarily used to aid in diagnosing, and how do they work?

The Aptiva APS IgG and IgM Reagents are designed to detect anticardiolipin antibodies (IgG and IgM isotypes) in human serum or plasma, helping to support the diagnosis of antiphospholipid syndrome (APS) and related autoimmune conditions. These reagents function as part of an immunological test system, quantifying antibody levels against cardiolipin to assist clinicians in identifying potential APS markers.

Are these reagents compatible with automated immunoassay systems, and how are they supplied?

Yes, the Aptiva APS IgG and IgM Reagents are supplied as ready-to-use components specifically designed for automated immunoassay systems. They are intended for single-use only, ensuring consistency and reducing contamination risks in clinical workflows.

What storage conditions are required for these reagents, and why is light protection important?

These reagents must be stored refrigerated between 2°C and 8°C and kept protected from light to maintain stability and accuracy. Light exposure can degrade the reagents, potentially leading to inaccurate test results, while refrigeration preserves their integrity for reliable diagnostic performance.

Are these reagents reusable, or do they need to be discarded after one use?

The Aptiva APS IgG and IgM Reagents are intended for single-use only, meaning each component should be used once and then discarded. This design minimizes cross-contamination risks and ensures consistent, high-quality results in clinical testing.

What regulatory pathways have these reagents undergone, and how does that affect their use?

The reagents are authorized under FDA 510(k) clearance and comply with the In Vitro Diagnostic Regulation (IVDR) in the EU. This means they meet U.S. and EU standards for safety, performance, and clinical utility, allowing them to be legally marketed and used in authorized regions for their intended diagnostic purposes.

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
Inova Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K223093 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026