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Liquichek ANA Control, Speckled Pattern, Positive, Catalog #108

FDA 510(k)

Class II (US FDA 510(k))

510(k) K024217

by Bio-Rad

Identifiers

510(k) Number
K024217 FDA 510(k)
FDA Product Code
DHN 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)

The Liquichek ANA Control, Speckled Pattern, Positive is an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control designed for quality assurance in immunology testing. It provides a standardized speckled pattern to verify the accuracy and precision of indirect immunofluorescence assays used to detect antinuclear antibodies (ANA) in human serum samples. This liquid, human serum-based control material is intended for use in laboratory settings to monitor assay performance and ensure reliable diagnostic results.

This control is supplied as a liquid, stored refrigerated at 2–8°C, and remains stable under these conditions. It is classified as a Class II device under FDA regulations (21 CFR 866.5100) and holds an FDA 510(k) clearance (K024217) for substantial equivalence in immunology applications. The product is intended for single-use in clinical laboratory settings and is not intended for direct patient administration.

Frequently asked questions

What is the Liquichek ANA Control, Speckled Pattern, Positive used for?

This control is designed for quality assurance in immunology testing, specifically to verify the accuracy and precision of indirect immunofluorescence assays used to detect antinuclear antibodies (ANA) in human serum samples. By providing a standardized speckled pattern, it helps laboratories monitor assay performance and ensure reliable diagnostic results.

How is the Liquichek ANA Control supplied and stored?

The control is supplied as a liquid, human serum-based material. It must be stored refrigerated between 2–8°C to maintain stability. Proper refrigeration ensures the control remains effective for its intended use in laboratory settings.

Is the Liquichek ANA Control intended for single-use or reuse?

This product is explicitly intended for single-use in clinical laboratory settings. It is not designed for reuse or direct patient administration, adhering to standard laboratory safety and quality control protocols.

What regulatory clearance does the Liquichek ANA Control hold?

The Liquichek ANA Control holds an FDA 510(k) clearance (K024217) under the classification of a Class II device (21 CFR 866.5100). This clearance confirms its substantial equivalence in immunology applications, ensuring compliance with U.S. regulatory standards.

How long can the Liquichek ANA Control remain stable under refrigeration?

The product remains stable when stored refrigerated at 2–8°C. While the exact shelf life isn’t specified in the data, proper refrigeration is required to preserve its integrity for use in quality assurance testing.

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 Urine Chemistry Control - Bio-Rad, Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108, Liquichek Immunology Control - Bio-Rad, K024217 FDA 510 (k) - LIQUICHEK ANA 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) K024217 24 fields · synced Oct 1, 2026