Tsh-Stat

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

510(k) Number

K844583 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Nuclear Medical Laboratories, Inc. →

• What clinical conditions is the TSH-STAT primarily used to diagnose or monitor?

  The TSH-STAT is designed for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma, aiding in the diagnosis and monitoring of thyroid disorders such as hypothyroidism and hyperthyroidism. Its competitive binding assay helps clinicians assess TSH levels to evaluate thyroid function.

• Is the TSH-STAT intended for single-use or repeated use in a clinical setting?

  The TSH-STAT is supplied as a single-use kit, meaning each kit is intended for one-time use in clinical chemistry laboratories. This design ensures consistency and safety, as reuse could compromise accuracy or introduce contamination risks.

• What safety precautions must be followed when handling the TSH-STAT?

  The TSH-STAT involves radioisotopes, so it requires adherence to standard radioisotope safety precautions during handling and use. The manufacturer’s instructions provide specific guidelines to ensure safe operation and minimize exposure risks.

• How is the TSH-STAT regulated in the U.S., and what does its classification mean?

  The TSH-STAT holds an FDA 510(k) clearance under product code JLW and is classified as a Class II medical device. This classification indicates it is subject to special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance, while still allowing for innovation in design.

• Are there any special storage requirements for the TSH-STAT beyond standard laboratory conditions?

  The TSH-STAT does not require special storage conditions beyond those outlined in the accompanying instructions. However, it must be stored and handled in compliance with radioisotope safety protocols to maintain integrity and accuracy of results.