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Anti-Cardiolipin Antibody (ACA) Screen ELISA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K970177

by Immco Diagnostics, Inc.

Identifiers

510(k) Number
K970177 FDA 510(k)
FDA Product Code
MID 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 an in vitro diagnostic test for the qualitative detection of anti-cardiolipin antibodies (ACA) in human serum or plasma using enzyme-linked immunosorbent assay (ELISA) technology. It falls under the classification of immunological tests, specifically designed to identify autoantibodies associated with antiphospholipid syndrome and other autoimmune conditions. The assay measures native ACA antibodies, distinguishing it from recombinant-based assays.

The Anti-Cardiolipin Antibody (ACA) Screen ELISA is supplied as a single-use diagnostic kit for laboratory use only. It is intended for use in clinical immunology settings and requires adherence to standard ELISA protocols, including sample preparation, incubation, and colorimetric detection. The device has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device (MID product code) under regulation 866.5660. No sterility or MRI safety considerations apply, as it is a non-invasive, reagent-based assay.

Frequently asked questions

What is the Anti-Cardiolipin Antibody (ACA) Screen ELISA used for?

This device is an in vitro diagnostic test designed to qualitatively detect native anti-cardiolipin antibodies (ACA) in human serum or plasma. It helps identify autoantibodies linked to antiphospholipid syndrome and other autoimmune conditions by using enzyme-linked immunosorbent assay (ELISA) technology. The assay distinguishes itself from recombinant-based tests by measuring natural ACA antibodies, aiding in clinical immunology evaluations.

How is the Anti-Cardiolipin Antibody (ACA) Screen ELISA supplied and intended for use?

The kit is supplied as a single-use diagnostic kit intended exclusively for laboratory use. It requires adherence to standard ELISA protocols, including sample preparation, incubation, and colorimetric detection. Clinicians must follow the provided instructions to ensure accurate results, as it is not intended for point-of-care or non-laboratory settings.

Is the Anti-Cardiolipin Antibody (ACA) Screen ELISA sterile, and what are its safety considerations?

This device is not sterile, as it is a reagent-based assay and not intended for invasive procedures. There are no MRI safety considerations, as it is a non-invasive diagnostic test. The kit is designed for laboratory use only, where standard biosafety practices should be followed to handle human serum or plasma samples.

What regulatory pathway and classification does the Anti-Cardiolipin Antibody (ACA) Screen ELISA follow?

The device received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II medical device under regulation 866.5660. This classification reflects its role as an immunological test for detecting ACA antibodies, ensuring it meets stringent performance standards for diagnostic accuracy and safety in clinical settings.

Are there different sizes or models available for the Anti-Cardiolipin Antibody (ACA) Screen ELISA?

The provided data does not specify multiple sizes or models for this particular device. It is supplied as a single-use kit designed for qualitative detection of ACA antibodies in human serum or plasma, adhering to a standardized ELISA protocol. For variations or additional formats, consult the manufacturer’s documentation or support.

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: ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA 510 (k)… - FDA.report, Human ACA ELISA Kit | Anti-Cardiolipin | MyBioSource, PDF K970177 - Anti-cardiolipin Antibody (Aca) Screen Elisa, Human ACA-IgG (Anti-Cardiolipin Antibody IgG) ELISA Kit, PDF PI5118 NOV2012 ce r1 - Immco Diagnostics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Immco Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K970177 24 fields · synced Oct 1, 2026