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QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuSta…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152875

by Inova Diagnostics, Inc.

Identifiers

510(k) Number
K152875 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)

This device is a Test System, Antibodies, B2-Glycoprotein I (B2-GPI) designed for the qualitative detection of anti-B2GPI antibodies in human serum or plasma. It employs immunoassay technology to identify IgG antibodies specific to domain 1 of B2-glycoprotein I, a marker associated with antiphospholipid syndrome diagnostics.

The QUANTA Flash B2GP1-Domain1 and HemosIL AcuStar Anti-B2GPI Domain 1 are intended for in vitro diagnostic use in clinical laboratories. Supplied as a reagent kit, the system includes test cartridges, controls, and reagents for automated immunoassay analysis on designated analyzers. The device is classified as Class II under FDA regulations and has received FDA 510(k) clearance and IVDD authorization, ensuring compliance with immunology testing standards.

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

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inova Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K152875 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026