Amizyme-Andna Test Kit

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

510(k) Number

K842533 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Amico Lab, Inc. →

• What is the Amizyme Andna Test Kit used for?

  The Amizyme Andna Test Kit is designed for the qualitative detection of antinuclear antibodies (ANA) in serum or plasma samples. ANA testing aids in diagnosing autoimmune diseases, such as systemic lupus erythematosus (SLE) and other connective tissue disorders. The kit uses enzyme-labeled antigens to produce a measurable colorimetric reaction, enabling trained laboratory personnel to interpret results for clinical decision-making.

• Is the Amizyme Andna Test Kit single-use or reusable?

  The Amizyme Andna Test Kit is supplied as a single-use diagnostic reagent. This design ensures consistency and reliability in test results while minimizing the risk of cross-contamination between samples. Each kit is intended for one-time use in a clinical laboratory setting by trained personnel.

• What components are included in the Amizyme Andna Test Kit?

  The kit includes enzyme-labeled antigens, necessary controls, and all other reagents required to perform the ANA test. These components work together to facilitate the detection of antinuclear antibodies through a standardized colorimetric process. The inclusion of controls helps validate the accuracy and reliability of each test run.

• How should the Amizyme Andna Test Kit be stored?

  While specific storage conditions and shelf life details are not explicitly provided in the regulatory data, the kit must be handled according to the manufacturer’s instructions to ensure optimal performance. Proper storage typically involves maintaining the kit in a clean, dry environment, protected from extreme temperatures and direct light, until use.

• What regulatory clearance does the Amizyme Andna Test Kit hold?

  The Amizyme Andna Test Kit holds FDA 510(k) clearance under the classification of Device Class II (866.5100), with the clearance number K842533. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in clinical laboratory settings.