Synelisa TGAB

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

510(k) Number

K915134 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

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 clinical conditions can the Synelisa TGAB help diagnose, and how does it work?

  The Synelisa TGAB is designed to detect thyroid peroxidase (TPO) antibodies in serum or plasma, which are linked to autoimmune thyroid diseases. By identifying these circulating autoantibodies, it aids in diagnosing conditions like Hashimoto’s thyroiditis and Graves’ disease, helping clinicians assess thyroid dysfunction. The test functions as a qualitative immunology assay, providing a yes/no result for antibody presence.

• Is the Synelisa TGAB intended for use outside of clinical laboratories, or is it strictly laboratory-based?

  The Synelisa TGAB is explicitly intended for use *only* in clinical laboratory settings. It is supplied as a single-use diagnostic kit, meaning it requires professional handling and interpretation by trained personnel in a controlled lab environment.

• How should the Synelisa TGAB be stored, and does it require any special handling?

  The Synelisa TGAB does not require special storage conditions beyond standard refrigeration. This makes it convenient for laboratories to maintain without additional infrastructure, though it should be kept in its original packaging until use.

• Is the Synelisa TGAB a reusable device, or is it designed for single-use only?

  The Synelisa TGAB is explicitly described as a single-use diagnostic kit. This design ensures patient safety and consistency, as each test is intended for one use only and cannot be reused or reprocessed.

• What regulatory pathway was followed for the Synelisa TGAB’s clearance, and what does that mean for its use?

  The Synelisa TGAB was cleared via the FDA’s Traditional 510(k) pathway (K915134) and is classified as a Class II device under product code JZO. This means it was determined to be substantially equivalent to a legally marketed device and is regulated under 21 CFR 866.5870 for immunology testing, ensuring it meets FDA safety and performance standards for clinical use.