ANA Test (Mouse Liver Substrate)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K820265 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Anti-Native Deoxyrib-Onucleic Acid Anti

  Class II

  FDA 510(k) K790252 Active Cleared 15 Mar 1979

• Anti-Nuclear Antibody Test

  Class II

  FDA 510(k) K791493 Active Cleared 24 Sep 1979

• Immunospot Tsh Test

  Class II

  FDA 510(k) K791065 Active Cleared 30 Jul 1979

• Meloy Lab-Antinuclear Antibody Test-Hep-2 Cell Cul

  Class II

  FDA 510(k) K844678 Active Cleared 4 Jan 1985

• Immunostat Tsh Test

  Class II

  FDA 510(k) K792562 Active Cleared 16 Jan 1980

• Meloy Autoantibody Test Sys

  Class II

  FDA 510(k) K842247 Active Cleared 26 Jun 1984

See all devices from Meloy Laboratories, Inc. →

• What is the ANA Test (Mouse Liver Substrate) used for in a clinical setting?

  The ANA Test (Mouse Liver Substrate) is an indirect immunofluorescence reagent designed to detect antinuclear antibodies (ANAs) in serum samples. It uses mouse liver tissue as a substrate to help identify autoimmune markers, which can aid in diagnosing conditions associated with systemic autoimmune diseases, such as lupus or other connective tissue disorders.

• Is this device intended for single-use or repeated use in a laboratory?

  This device is explicitly intended for single-use applications in clinical immunology laboratories. It is not designed for reuse, as its performance may be compromised after a single use.

• How should the ANA Test (Mouse Liver Substrate) be stored according to the manufacturer’s instructions?

  The device requires storage under controlled conditions as specified by Meloy Laboratories, Inc. While the exact storage details (e.g., temperature, humidity) are not provided here, it is critical to follow the manufacturer’s guidelines to maintain its integrity and functionality for accurate testing.

• What regulatory pathway was followed for FDA clearance of this device?

  The ANA Test (Mouse Liver Substrate) received FDA clearance through a Traditional 510(k) pathway, classified under Class II medical devices. The submission was reviewed by the Immunology (IM) Advisory Committee and determined to be substantially equivalent to a predicate device, adhering to regulatory standards for immunoassay controls.

• Is this device supplied as a standalone kit, or does it require additional components for use?

  The ANA Test (Mouse Liver Substrate) is supplied as a diagnostic reagent for in vitro use, meaning it is intended to be part of a broader immunofluorescence testing workflow. While the exact components (e.g., slides, diluents) are not detailed here, it is designed to be used alongside standard laboratory equipment and consumables for ANA detection.