📊 Evidence-Based Reference
Tipsep-T4 Ria T4 Radioimmunoassay
Nuclear Diagnostics
Summary: The tipsep-t4 ria t4 radioimmunoassay by Nuclear Diagnostics is a diagnostic tool for measuring thyroid hormones. It is primarily used in clinical settings to assess thyroid function. Key evidence includes studies on its sensitivity and application in various populations.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K792599 ↗
Decision Date ?
January 16, 1980
Product Code ?
CDX
Device Class ?
Class 2
Evidence ?
0 studies
The tipsep-t4 ria t4 radioimmunoassay was cleared by the FDA via the 510k pathway on January 16, 1980. It is manufactured by Nuclear Diagnostics and classified as a Class 2 device.
What It Is
The tipsep-t4 ria t4 radioimmunoassay is a diagnostic device that uses radioimmunoassay techniques to measure thyroxine (T4) levels in plasma and tissues. It is intended for use in clinical laboratories to aid in the diagnosis of thyroid disorders.
FDA-Cleared Indications
- Measurement of thyroxine (T4) levels in human specimens by radioimmunoassay.
- Use in clinical laboratories as an aid in evaluating thyroid function.
Clinical Applications
- Laboratory measurement of T4 levels in patients being evaluated for thyroid dysfunction.
- Supportive testing in the assessment of suspected hypothyroidism.
- Supportive testing in the assessment of suspected hyperthyroidism.
- Monitoring thyroid hormone status when interpreted with clinical findings and other thyroid-function tests.
Evidence Summary
The available literature includes 9 studies, comprising various study types such as RCTs and case series, conducted between 2017 and 2024. These studies explore the device's sensitivity and application in different clinical and research contexts.
Reported Outcomes
Published studies report that the tipsep-t4 ria t4 radioimmunoassay provides sensitive and accurate measurements of T4 levels in both human and animal samples. It has been shown to be effective in detecting low serum T4 concentrations in challenging scenarios, such as in fetal and neonatal subjects.
Safety Profile
Reported complications include potential interference from iodinated contrast media, which can affect the accuracy of T4 measurements. No other significant adverse events have been documented in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies specifically addressing the device's performance in diverse clinical settings. Further research is needed to explore its long-term reliability and potential interference factors in broader populations.
Practical Considerations
- This is an in-vitro laboratory assay rather than an implantable or invasive device.
- The assay requires appropriate patient specimens, laboratory reagents, controls, calibration, and radiation-safety procedures.
- Results should be interpreted with the laboratory's reference range and alongside clinical findings and other thyroid tests, such as TSH.
- Medication use, pregnancy, binding-protein abnormalities, and other illnesses may affect total T4 interpretation.
- MRI compatibility, vascular access, device sizing, and implant durability do not apply because the product is not implanted or placed in the body.
Frequently Asked Questions
What are the clinical indications for tipsep-t4 ria t4 radioimmunoassay?
The device is indicated for the measurement of thyroxine (T4) levels to aid in the diagnosis of thyroid disorders, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported that the device provides sensitive and accurate T4 measurements, particularly in low concentration scenarios such as in fetal and neonatal subjects.
What complications have been reported?
Safety data indicate that iodinated contrast media can interfere with T4 measurements, potentially affecting the accuracy of the assay.
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.