FDA 510K for Thyroid Stimulating Hormone Test System
The Thyroid Stimulating Hormone (TSH) Test System is designed to measure the level of TSH in the blood, which is produced by the pituitary gland. This test is crucial for assessing thyroid function and can indicate if the thyroid is working properly, as abnormal TSH levels may signal conditions such as Hyperthyroidism (overactive thyroid) or Hypothyroidism (underactive thyroid). Advanced TSH testing methods, like the TSH FIA Test, allow for rapid detection of circulating TSH in serum or plasma without the need for extensive laboratory equipment, providing results within about 20 minutes.
Intended Use of Thyroid stimulating hormone
Thyroid Stimulating Hormone Test System is a device intended to measure thyroid-stimulating hormone, also known as Thyrotrophin and Thyrotrophic Hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Thyroid Stimulating Hormone Test System
FDA 510K for Thyroid Stimulating Hormone Test System Device Code and Regulation Number
| S.
NO |
Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | Thyroid stimulating hormone test system. | 862.169 | 2 |
Thyroid Stimulating Hormone Test System
Intended Use:
Intended for quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders.
Device Description:
System is used for quantitative measurement of TSH in specimens using CLEIA technology. The system uses a two-step sandwich immunoassay method on particles, where TSH binds to anti-human TSH monoclonal antibody (mouse) and forms antigen-antibody immunocomplexes. The particles are washed and rinsed to remove unbound materials. Alkaline phosphatase (ALP)-labeled anti-human TSH monoclonal antibody binds to TSH of the immunocomplexes on particles, forming additional immunocomplexes. Substrate Solution is added and mixed with the particles, and AMPPDAMPPD (3-(2′-spiroadamantyl)-4-methoxy-4-(3″-phosphoryloxy)-phenyl-1,2-dioxetane) is a chemiluminescent substrate for alkaline phosphatase that is nonradioactive labeling systems,
is dephosphorylated by ALP. The luminescent signal reflects the amount of TSH.
Performance Testing (Analytical) for Thyroid Stimulating Hormone Test System
- Reagent Stability
- Precision/Reproducibility
- Detection studies- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)
- Linearity/assay reportable range
- Traceability (controls, calibrators, or method)
- Analytical specificity
- Analytical Sensitivity
- Interfering Substances
Clinical Testing:
No Guidance available for 510k submission.