Diastat Anti-Thyroid Peroxidase Kit

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

510(k) Number

K951487 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Shield Diagnostics, Ltd. →

• What is the Diastat Anti-Thyroid Peroxidase Kit used for in clinical practice?

  The Diastat Anti-Thyroid Peroxidase Kit is designed for the qualitative detection of antibodies to thyroid peroxidase (anti-TPO) in human serum or plasma. These antibodies are linked to autoimmune thyroid diseases like Hashimoto’s thyroiditis and Graves’ disease, so the test helps identify patients who may have these conditions. It is intended strictly for laboratory use to screen for autoimmune thyroid disorders.

• Is this kit single-use, or can it be reused across multiple patients?

  The Diastat Anti-Thyroid Peroxidase Kit is explicitly labeled as a single-use diagnostic test. This means each kit is intended for one test procedure only and should not be reused for multiple patients or samples to ensure accuracy and prevent contamination.

• What storage conditions should be followed for this kit, and are there any special handling requirements?

  The provided data does not specify storage conditions for the Diastat Anti-Thyroid Peroxidase Kit. However, as with most diagnostic reagents, it is generally recommended to store the kit in a cool, dry place away from direct sunlight and extreme temperatures. Always refer to the manufacturer’s instructions included with the kit for precise storage guidance.

• How was the regulatory pathway for this device determined, and what does the product code (JZO) indicate?

  The Diastat Anti-Thyroid Peroxidase Kit was cleared through the FDA’s 510(k) process, specifically under the Traditional pathway, and was deemed substantially equivalent to a predicate device. The product code JZO categorizes this device under the FDA’s classification system for in vitro diagnostic tests, particularly those related to immunology. This code reflects its use in detecting thyroid autoantibodies, aligning with the Immunology advisory committee (IM) that reviewed it.