ELIAS ANA-HEP-2

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K964385 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Elias Ena Screen (Microtiter Plate)

  Class II

  FDA 510(k) K940622 Active Cleared 11 May 1994

• Varelisa Helicobacter Pylori Antibodies

  Class I

  FDA 510(k) K953873 Active Cleared 30 Aug 1996

• Varelisa Combined DNA Antibodies Eia

  Class II

  FDA 510(k) K944334 Active Cleared 17 Apr 1995

• Synelisa Tgab/Tmab

  Class II

  FDA 510(k) K915135 Active Cleared 8 Apr 1992

• Synelisa Cardiolipin Antibodies

  Class II

  FDA 510(k) K924421 Active Cleared 30 Nov 1992

• Syn Elisa Micro Albumin

  Class I

  FDA 510(k) K920216 Active Cleared 11 Mar 1992

See all devices from Elias U.S.A., Inc. →

• What autoimmune diseases can the ELIAS ANA-HEP-2 help diagnose?

  The ELIAS ANA-HEP-2 is designed to identify specific autoantibodies linked to autoimmune conditions such as systemic lupus erythematosus, hepatitis, rheumatoid arthritis, and systemic sclerosis. It achieves this through enzyme-labeled techniques that measure antigen-antibody reactions, providing measurable evidence via colorimetric or fluorometric endpoints. This aids clinicians in differentiating these conditions during diagnostic workup.

• How is the ELIAS ANA-HEP-2 supplied and prepared for use?

  The ELIAS ANA-HEP-2 is supplied as a single-use diagnostic kit intended exclusively for laboratory use. It requires reconstitution and preparation according to the manufacturer’s detailed instructions. The kit includes antigen controls and is meant to be used by trained personnel in immunology laboratories under controlled conditions to ensure accurate and reliable assay results.

• Is the ELIAS ANA-HEP-2 sterile and intended for single-use?

  Yes, the ELIAS ANA-HEP-2 is designed for single-use only. While the device data does not explicitly state sterility, its classification as an in vitro diagnostic (IVD) kit for laboratory use implies adherence to standard IVD protocols, which typically include sterility for single-use diagnostic reagents. Always follow the manufacturer’s storage and handling guidelines to maintain assay integrity.

• What regulatory pathway does the ELIAS ANA-HEP-2 follow?

  The ELIAS ANA-HEP-2 is classified under FDA regulation 866.5100 and falls under Device Class II. It holds an FDA 510(k) clearance (K964385) for substantial equivalence, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance was granted by the FDA’s Immunology (IM) Advisory Committee in 1997, ensuring it meets the necessary safety and performance standards for its intended use.

• How should the ELIAS ANA-HEP-2 be stored to preserve its functionality?

  The ELIAS ANA-HEP-2 must be stored and handled according to standard in vitro diagnostic (IVD) protocols to maintain its assay integrity. While specific storage conditions (e.g., temperature, humidity) are not detailed here, it is critical to follow the manufacturer’s instructions provided with the kit. Improper storage could compromise the accuracy of results, so always ensure the kit is stored in a controlled environment as recommended.