Ria Diag. Test Kit For Indexing Thyrox.

This RIA Diagnostic Test Kit for Indexing Thyroxine is specifically designed to measure free thyroxine (T4) levels in clinical chemistry, enabling quantitative assessment of thyroid function. Unlike some tests that measure total T4 (bound and unbound), this kit focuses on free T4, which is the biologically active fraction of the hormone. This distinction helps clinicians diagnose and monitor thyroid disorders—such as hyperthyroidism or hypothyroidism—by providing precise measurements of unbound thyroxine, which is critical for accurate thyroid function evaluation.

The kit is explicitly labeled as a single-use diagnostic reagent, meaning each kit is designed for one test cycle only. Reusing it could compromise accuracy, reliability, and sterility, which are essential for valid clinical results. Always follow the manufacturer’s instructions for proper handling and disposal to maintain test integrity.

The kit received FDA 510(k) clearance (K781560) under the Traditional 510(k) pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, ensuring compliance with FDA standards for Class II diagnostic devices. Clinicians can rely on this clearance as evidence of the kit’s safety and effectiveness for measuring free thyroxine in laboratory settings, though adherence to manufacturer guidelines remains critical for accurate results.

While the exact storage conditions aren’t detailed in the provided data, all RIA test kits—including this one—typically require proper storage per manufacturer instructions to preserve sterility, stability, and performance. This usually involves refrigeration (e.g., 2–8°C) and protection from light, moisture, or extreme temperatures. Failure to store it correctly may lead to degraded reagents or inaccurate test results, so always refer to the accompanying documentation for precise guidelines.

The classification under the Clinical Chemistry advisory committee (CH) indicates that this kit is intended for use in specialized laboratory settings where precise hormone quantification is performed. This classification helps labs identify the appropriate workflows, quality control protocols, and training requirements for handling RIA-based assays. Clinicians should ensure their laboratory has the necessary infrastructure—such as radiochemistry expertise and proper disposal systems—to safely and accurately use this device for thyroid function assessment.