Synelisa Cardiolipin Antibodies

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

510(k) Number

K921250 ↗

FDA Product Code

MID

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  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

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  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 anticardiolipin antibodies does this test detect, and how is it used in clinical practice?

  The Synelisa Cardiolipin Antibodies test detects immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) anticardiolipin antibodies in human serum or plasma. Clinically, it aids in diagnosing and monitoring antiphospholipid syndrome, an autoimmune condition linked to increased risks of blood clots and pregnancy complications. The assay provides qualitative or quantitative results to help guide patient management.

• Is this test intended for single-use only, and if so, why?

  Yes, the Synelisa Cardiolipin Antibodies test is designed for single-use only, as stated in the reagent kit specifications. This ensures accuracy and reliability by preventing cross-contamination between samples, which could compromise test results and patient safety in laboratory settings.

• What storage conditions must be followed to maintain the stability of the reagents in this kit?

  The manufacturer’s instructions must be strictly followed for storage, though the exact conditions are not detailed in the provided data. Proper storage is critical to preserve reagent stability, as improper handling could lead to inaccurate test results. Always refer to the included documentation for precise guidelines.

• How is this device regulated, and what pathway was used for its FDA clearance?

  The Synelisa Cardiolipin Antibodies is regulated as a Class II in vitro diagnostic device under the FDA’s Traditional 510(k) pathway, with a product code of MID (Medical Imaging and Diagnostic). It was cleared as substantially equivalent to a predicate device, meaning it meets FDA requirements for safety and effectiveness under 21 CFR Part 820 and related quality system regulations.

• Can this test be used in conjunction with MRI procedures, or does it have any MRI-related limitations?

  The Synelisa Cardiolipin Antibodies test is explicitly stated as not MRI-compatible, meaning it should not be used in or near MRI environments. This limitation is due to potential interference from magnetic fields, which could affect the integrity of the test reagents or results.