Tipsep-Cortisol Ria Diagnostic Kit

FDA-Cleared Indications

• In vitro quantitative measurement of cortisol in human biological samples.
• Use as an aid in the evaluation of adrenal function.

Clinical Applications

• Laboratory measurement of cortisol concentrations.
• Evaluation of suspected disorders of adrenal cortisol production.
• Assessment of cortisol results in the clinical workup of adrenal function.

Reported off-label uses

• Research measurement of cortisol in studies of stress, endocrine physiology, and cortisol-related disorders.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• This is an in vitro diagnostic assay, not an implantable or therapeutic device.
• The kit uses radioactive reagents and must be handled, stored, and disposed of according to the product labeling and applicable radiation-safety requirements.
• Results can be affected by specimen type, collection timing, medications, binding-protein changes, and assay interference; interpretation should follow the laboratory’s validated procedures.
• It is not an MRI-compatible device because it is a laboratory assay rather than equipment used in or on the patient during MRI.
• The kit does not have a patient-contacting size, vessel compatibility requirement, or procedural implant duration.