Varelisa ANA Profile

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

510(k) Number

K951205 ↗

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 types of samples can the Varelisa ANA Profile test, and how is it used in a clinical setting?

  The Varelisa ANA Profile is designed to measure antinuclear antibodies (ANAs) in serum, body fluids, or tissue samples using immunochemical techniques. It detects antibodies reacting with nuclear constituents like RNA, which are markers for autoimmune diseases such as systemic lupus erythematosus (SLE) and connective tissue disorders. This assay is intended for laboratory use only and requires validation by trained personnel to ensure accurate results.

• Is the Varelisa ANA Profile intended for single-use or repeated testing, and how should it be handled?

  The Varelisa ANA Profile is intended for single-use only and does not require additional sterilization beyond the manufacturer’s provided protocols. Since it is a reagent-based system, proper storage and handling per the manufacturer’s guidelines are critical to maintain reagent integrity and reliability. This ensures each test remains accurate and free from contamination.

• What regulatory pathway does the Varelisa ANA Profile follow, and what does that mean for its use?

  The Varelisa ANA Profile follows the FDA 510(k) clearance pathway, specifically under traditional review and classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device and is regulated under FDA product code LJM (866.5100) for immunology applications. This means it has undergone FDA review for safety and performance but does not imply any specific clinical indication beyond its labeled use for detecting ANAs.

• Are there any special storage requirements or considerations for the Varelisa ANA Profile?

  The Varelisa ANA Profile must be stored and handled according to the manufacturer’s guidelines to preserve reagent integrity. While no specific MRI safety considerations are noted, proper temperature control, protection from light, and adherence to expiration dates are essential for maintaining test accuracy. The system is not designed for reuse, so unused reagents should be discarded appropriately after opening.