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Liquichek Anti-SS-A Control, Positive, Catalog #114

FDA 510(k)

Class II (US FDA 510(k))

510(k) K024218

by Bio-Rad

Identifiers

510(k) Number
K024218 FDA 510(k)
FDA Product Code
LKJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5100 FDA 510(k)
Regulation Number
866.5100 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Liquichek Anti-SS-A Control, Positive is a human serum-based, liquid, unassayed quality control material. It is used by laboratory personnel to monitor the performance of indirect immunofluorescent testing for SS-A autoantibodies.

The control is stored at 2-8°C and provides a stable reference to ensure assay accuracy and reliability. It is classified as an Antinuclear Antibody, Antigen, Control under product code LKJ, Class II, with FDA 510(k) clearance K024218 granted on January 17, 2003.

Frequently asked questions

What is the Liquichek Anti-SS-A Control, Positive used for in a clinical laboratory setting?

The Liquichek Anti-SS-A Control, Positive is a human serum-based liquid control designed to monitor the performance of indirect immunofluorescent testing for SS-A autoantibodies. It serves as a stable reference material to help ensure assay accuracy and reliability, allowing laboratory personnel to verify the consistency of their testing procedures.

Is this control material single-use or reusable, and how should it be stored?

This control is intended for single-use as a quality control material. It should be stored refrigerated between 2°C and 8°C to maintain stability and ensure accurate performance when used for monitoring immunofluorescent assays.

What regulatory pathway was followed for this device, and what classification does it hold?

The Liquichek Anti-SS-A Control, Positive was cleared through the FDA’s 510(k) pathway under the Traditional review process, with a decision of Substantially Equivalent (SESE). It is classified as a Class II device under product code LKJ, specifically categorized as an Antinuclear Antibody, Antigen, Control.

What form does the control come in, and is it pre-assayed or unassayed?

The control is supplied as a liquid, human serum-based material in its unassayed form. This means it is not pre-measured or tested for SS-A autoantibodies and must be used directly in the laboratory’s immunofluorescent testing workflow to validate assay performance.

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: Liquichek Anti-ss-a Control, Positive, Catalog #114, K024218 FDA 510(k) - LIQUICHEK ANTI-SS-A CONTROL | Bio-Rad, K024218 FDA 510(k) - LIQUICHEK ANTI-SS-A CONTROL | Bio-Rad

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K024218 24 fields · synced Sep 19, 2026