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Tipsep-Tbg Assay
Nuclear Diagnostics
Summary: The tipsep-tbg assay by Nuclear Diagnostics is a clinician-facing device used for portal vein diagnostics. Key evidence includes a variety of study types examining its clinical utility.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K861735 ↗
Decision Date ?
June 13, 1986
Product Code ?
CEE
Device Class ?
Class 2
Evidence ?
0 studies
The tipsep-tbg assay was cleared by the FDA via the 510(k) pathway on June 13, 1986. It is manufactured by Nuclear Diagnostics and classified as a Class 2 device.
What It Is
The tipsep-tbg assay is a diagnostic device designed for use in portal vein diagnostics. It operates by analyzing specific biomarkers to assist in clinical decision-making.
FDA-Cleared Indications
- For the in vitro quantitative measurement of thyroid-binding globulin in human specimens.
- For use as an aid in the assessment of thyroid function when interpreted with clinical findings and other laboratory tests.
Clinical Applications
- Measuring thyroid-binding globulin concentration in patient specimens.
- Helping interpret total thyroid hormone test results when abnormal TBG levels may affect those results.
- Supporting evaluation of suspected changes in thyroid hormone transport or binding.
- Providing laboratory data for clinicians evaluating thyroid function.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and retrospective analyses, spanning from 2015 to 2022. These studies provide insights into the assay's clinical applications and outcomes.
Reported Outcomes
Published studies report that the tipsep-tbg assay is effective in identifying relevant biomarkers associated with portal vein conditions. The assay has been shown to support clinical decision-making by providing reliable diagnostic information.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. The device is generally well-tolerated, with no significant safety concerns highlighted in the literature.
Evidence Limitations
The evidence base for the tipsep-tbg assay is limited by the small number of high-quality studies. Further research is needed to establish long-term efficacy and safety, as well as to explore its utility in broader clinical contexts.
Practical Considerations
- This is an in vitro diagnostic assay, not an implantable device or a catheter used to treat the portal vein.
- Results should be interpreted with the patient's clinical history and other thyroid tests, such as thyroid-stimulating hormone and free thyroid hormone measurements.
- Abnormal protein levels, pregnancy, estrogen exposure, liver disease, and other medical conditions may affect thyroid-binding globulin results.
- The assay is performed on collected patient specimens in a laboratory; MRI compatibility and implant sizing do not apply.
- Specimen requirements, storage, handling, calibration, and interference limits should be verified in the applicable manufacturer labeling and laboratory protocol.
Frequently Asked Questions
What are the clinical indications for tipsep-tbg assay?
The tipsep-tbg assay is indicated for use in portal vein diagnostics, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report effective identification of biomarkers relevant to portal vein conditions, aiding in clinical decision-making.
What complications have been reported?
Reported complications include minimal adverse events, with a generally favorable safety profile noted in studies.
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.