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Autostat Ii Anti-B-2 Glycoprotein-I Igm Elisa

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022944

by Hycor Biomedical, Inc.

Identifiers

510(k) Number
K022944 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 Autostat II Anti-B2 Glycoprotein-I IgM ELISA is an enzyme-linked immunosorbent assay (ELISA) system designed for the semi-quantitative detection of IgM autoantibodies against B2-glycoprotein-I in human serum. This diagnostic test supports the identification of autoimmune conditions, including antiphospholipid syndrome, by quantifying specific antibody levels. It operates as a component of a multi-factorial diagnostic workflow to assist clinicians in evaluating autoimmune-related pathologies. The device adheres to the classification of a system for antibody testing under regulatory frameworks.

This assay is intended for use in clinical laboratory settings and is compatible with the Hycor HY.TEC automated enzyme immunoassay (EIA) instrument. Supplied as a single-use diagnostic reagent, the device requires no special sterility beyond standard laboratory protocols. It is classified under FDA device class II (MSV product code) and has received a 510(k) clearance through a traditional review pathway by the Immunology (IM) advisory committee. Storage and handling follow standard laboratory practices for immunoassay reagents, with no specific MRI safety considerations.

Frequently asked questions

What is the Autostat II Anti-B2 Glycoprotein-I IgM ELISA used for?

This ELISA system is designed for the semi-quantitative detection of IgM autoantibodies against B2-glycoprotein-I in human serum. It supports the identification of autoimmune conditions, including antiphospholipid syndrome, by quantifying specific antibody levels as part of a multi-factorial diagnostic workflow.

How is the Autostat II Anti-B2 Glycoprotein-I IgM ELISA supplied and handled?

The device is supplied as a single-use diagnostic reagent that requires no special sterility beyond standard laboratory protocols. It is compatible with the Hycor HY.TEC automated enzyme immunoassay instrument and follows standard laboratory practices for storage and handling of immunoassay reagents.

What is the regulatory classification of the Autostat II Anti-B2 Glycoprotein-I IgM ELISA?

This device is classified under FDA device class II (MSV product code) and has received 510(k) clearance through a traditional review pathway by the Immunology (IM) advisory committee. It is intended for use in clinical laboratory settings as a system for antibody testing.

Is the Autostat II Anti-B2 Glycoprotein-I IgM ELISA a single-use or reusable device?

The Autostat II Anti-B2 Glycoprotein-I IgM ELISA is supplied as a single-use diagnostic reagent. Each test is designed for one-time use and should not be reused or repurposed for additional testing to ensure accurate results.

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: Autostat Ii Anti-b-2 Glycoprotein-i Igm Elisa, Autostat Ii Anti-b-2 Glycoprotein I Igg Elisa, AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hycor Biomedical, Inc.

Sources (1)

  • FDA 510(k) K022944 24 fields · synced Oct 1, 2026