Thyroid Stimulating Hormone

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

510(k) Number

K792154 ↗

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 Radioimmunoassay, Inc. →

• What types of samples can the Thyroid Stimulating Hormone Radioimmunoassay Kit measure, and why is this important for clinical use?

  The Thyroid Stimulating Hormone (TSH) Radioimmunoassay Kit is designed to quantitatively measure TSH levels in serum and heparin plasma. This dual-sample compatibility is important because serum is commonly used for routine blood tests, while heparin plasma may be preferred in specific clinical scenarios (e.g., anticoagulation monitoring or pediatric samples) to avoid clotting artifacts. Accurate TSH measurement is critical for diagnosing thyroid disorders like hypothyroidism or hyperthyroidism, so the kit’s flexibility ensures broader diagnostic utility.

• Is this kit single-use, and if so, what does that mean for workflow efficiency in a clinical lab?

  Yes, the TSH Radioimmunoassay Kit is explicitly supplied as a single-use diagnostic kit. This means each kit is intended for one test cycle, reducing the risk of cross-contamination and ensuring consistent, reliable results. For lab workflows, this implies you’ll need to account for kit inventory management and avoid reuse, which may impact throughput if large volumes are tested. However, it aligns with best practices for in vitro diagnostics to maintain precision and patient safety.

• How is the regulatory pathway for this device structured, and what does the 510(k) clearance indicate about its clinical chemistry application?

  The kit holds a 510(k) clearance under the FDA’s Traditional pathway, classified as a Class II device (code 862.1690) with a substantially equivalent (SESE) determination. This clearance confirms the device is deemed equivalent to a legally marketed predicate in clinical chemistry applications, meaning it meets FDA standards for safety and effectiveness in measuring TSH levels. The advisory committee designation (CH: Clinical Chemistry) further specifies its intended use within that specialty, ensuring compliance with regulatory expectations for diagnostic accuracy.

• Are there specific storage requirements for the kit, and why might these matter for maintaining test validity?

  While the exact storage instructions aren’t detailed in the provided data, the kit’s diagnostic nature and single-use design imply it requires adherence to manufacturer guidelines (likely outlined in the accompanying instructions) to preserve reagent stability and sterility. Improper storage—such as exposure to extreme temperatures or light—could degrade components, leading to inaccurate TSH measurements. For labs, this means integrating the kit into a controlled storage system (e.g., refrigeration) to ensure consistent, valid results across all tests.