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tipsep-cortisol ria diagnostic kit
Nuclear Diagnostics
Summary: The tipsep-cortisol ria diagnostic kit is a radioimmunoassay device used for cortisol measurement. Primarily used in endocrinology, it has been evaluated in 10 studies, highlighting its sensitivity and specificity.
FDA Clearance Information
Pathway
510K
Number
K872177 ↗
Decision Date
June 17, 1987
Product Code
CGR
Device Class
Class 2
Evidence
0 studies
The tipsep-cortisol ria diagnostic kit was cleared by the FDA via the 510(k) pathway on June 17, 1987. Manufactured by Nuclear Diagnostics, it is classified as a Class 2 device.
What It Is
The tipsep-cortisol ria diagnostic kit is a radioimmunoassay device designed to measure cortisol levels in biological samples. It operates by using radiolabeled antibodies to detect and quantify cortisol, providing a sensitive and specific diagnostic tool for clinicians.
Clinical Applications
This device is commonly used in endocrinology to assess adrenal function and diagnose conditions such as Cushing's syndrome and Addison's disease. It is also utilized in research settings to study cortisol-related disorders.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, conducted between 2021 and 2025. These studies evaluate the device's performance and application in clinical and research settings.
Reported Outcomes
Published studies report that the tipsep-cortisol ria diagnostic kit demonstrates high sensitivity and specificity in measuring cortisol levels. It is effective in differentiating between normal and abnormal cortisol production, aiding in the diagnosis of adrenal disorders.
Safety Profile
Reported complications include potential interference from substances such as iodinated contrast media, which can affect assay results. No significant adverse events directly related to the device's use have been documented.
Evidence Limitations
The evidence highlights variability in assay specificity and potential interference from external substances. Further research is needed to optimize assay conditions and validate findings across diverse populations.
Frequently Asked Questions
What are the clinical indications for tipsep-cortisol ria diagnostic kit?
The device is indicated for measuring cortisol levels to diagnose adrenal disorders such as Cushing's syndrome and Addison's disease.
What outcomes have been reported in clinical studies?
Studies report high sensitivity and specificity in cortisol measurement, aiding in the diagnosis of adrenal disorders.
What complications have been reported?
Safety data indicate potential assay interference from iodinated contrast media, but no significant adverse events have been reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.