📊 Evidence-Based Reference
Serum Thyrotropin Assay Kit Tipsep-
Nuclear Diagnostics
Summary: The serum thyrotropin assay kit tipsep- by Nuclear Diagnostics is used for measuring thyroid-stimulating hormone (TSH) levels. Key evidence highlights its role in diagnosing thyroid disorders and its correlation with metabolic diseases.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K833713 ↗
Decision Date ?
December 29, 1983
Product Code ?
JLW
Device Class ?
Class 2
Evidence ?
0 studies
The serum thyrotropin assay kit tipsep- was cleared by the FDA via the 510(k) pathway on December 29, 1983. It is manufactured by Nuclear Diagnostics and classified as a Class 2 device.
What It Is
The serum thyrotropin assay kit tipsep- is a diagnostic tool designed to measure serum TSH levels, aiding in the diagnosis and management of thyroid disorders. It is intended for use in clinical settings to assess thyroid function.
FDA-Cleared Indications
- Measurement of serum thyrotropin (TSH) levels.
- In vitro assessment of thyroid function.
- Use as an aid in the diagnosis of thyroid disorders.
Clinical Applications
- Testing serum TSH during evaluation of suspected thyroid dysfunction.
- Laboratory assessment of thyroid function in adults.
- Laboratory assessment of thyroid function in neonatal or pediatric populations when included in the applicable labeling.
- Supporting clinical evaluation of patients with abnormal thyroid-related symptoms or laboratory findings.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to retrospective analyses, published between 2015 and 2025. These studies explore the relationship between TSH levels and various health conditions.
Reported Outcomes
Published studies report that the serum thyrotropin assay kit is effective in establishing reference intervals for TSH in both adults and neonates. It has been linked to metabolic disease assessment in older adults and provides a non-invasive alternative for patients unable to undergo venepuncture.
Safety Profile
Reported complications include the potential for variability in TSH measurement when using dried blood spot samples compared to serum samples. No significant adverse events have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials directly comparing the assay kit to other diagnostic methods. Further research is needed to establish standardized reference intervals across diverse populations.
Practical Considerations
- This is an in vitro diagnostic assay, not an implantable or therapeutic device.
- Testing requires a serum specimen collected and handled according to the assay instructions and laboratory requirements.
- Results should be interpreted with the patient's clinical findings and other thyroid laboratory tests.
- The assay is not evaluated for MRI safety because it is not used inside the body.
- Use, calibration, quality control, specimen stability, and interference limits should follow the manufacturer's labeling and the laboratory's validated procedures.
Frequently Asked Questions
What are the clinical indications for serum thyrotropin assay kit tipsep-?
The kit is indicated for measuring TSH levels to diagnose and manage thyroid disorders, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported effective TSH measurement and established reference intervals for adults and neonates.
What complications have been reported?
Safety data indicate variability in TSH measurement with dried blood spot samples, but no significant adverse events are noted.
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.