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Tipsep-T3u Triiodothyronine Uptake
Nuclear Diagnostics
Summary: The tipsep-t3u triiodothyronine uptake device by Nuclear Diagnostics is used for assessing thyroid function. Key evidence includes studies on cellular uptake of triiodothyronine.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K792484 ↗
Decision Date ?
December 27, 1979
Product Code ?
KHQ
Device Class ?
Class 2
Evidence ?
0 studies
The tipsep-t3u triiodothyronine uptake device was cleared via the FDA 510(k) pathway on December 27, 1979. It is manufactured by Nuclear Diagnostics and classified as a Class 2 device.
What It Is
The tipsep-t3u triiodothyronine uptake device measures the uptake of triiodothyronine, a thyroid hormone, to assess thyroid function. It is intended for use in clinical settings to aid in the diagnosis of thyroid disorders.
FDA-Cleared Indications
- For the in vitro measurement of triiodothyronine uptake in human blood or serum.
- For use as an aid in the assessment of thyroid function.
Clinical Applications
- Laboratory evaluation of thyroid function.
- Assessment of triiodothyronine uptake alongside other thyroid hormone tests.
- Diagnostic workup of suspected thyroid disorders in clinical laboratory settings.
Evidence Summary
The available literature includes 10 studies, ranging from 1994 to 2011, with various study designs including RCTs and observational studies. These studies focus on the uptake of triiodothyronine in different cellular models.
Reported Outcomes
Published studies report that triiodothyronine uptake varies across different cell types, with significant uptake observed in cardiomyocytes and erythrocytes. The studies highlight the role of triiodothyronine in cellular metabolism and its potential impact on thyroid function assessment.
Safety Profile
Reported complications include potential interference with other thyroid function tests and variability in uptake measurements. No major adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the focus on cellular models rather than clinical outcomes. Further research is needed to establish the clinical utility and standardize the uptake measurement process.
Practical Considerations
- This is an in vitro diagnostic test, not an implanted or interventional device.
- The test result should be interpreted with other laboratory findings and the patient's clinical condition.
- It does not directly measure the amount of triiodothyronine circulating in the blood.
- MRI compatibility, device sizing, and vascular access are not applicable.
- Specimen collection, storage, reagent handling, calibration, and quality control should follow the product labeling and laboratory procedures.
Frequently Asked Questions
What are the clinical indications for tipsep-t3u triiodothyronine uptake?
The device is indicated for assessing thyroid function by measuring triiodothyronine uptake, aiding in the diagnosis of thyroid disorders.
What outcomes have been reported in clinical studies?
Studies report significant uptake of triiodothyronine in various cell types, indicating its role in thyroid function assessment.
What complications have been reported?
Reported complications include potential interference with other thyroid tests and variability in uptake measurements.
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.