(123 days)
An Enzyme Immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delaved or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
The DRG Salivary Testosterone ELISA Kit is based on the competition princible and the microplate separation. An unknown amount of free testosterone present in the sample and a fixed amount of testosterone conjugated with horseradish peroxidase compete for the binding sites of mouse monoclonal testosterone -antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the substrate solution the concentration of testosterone is inversely proportional to the optical density measured.
The DRG Salivary Testosterone ELISA is a diagnostic device used for the quantitative measurement of free-active testosterone in saliva. The device performance was evaluated through various studies, including method comparison, sensitivity, specificity, reproducibility, recovery, and linearity.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Normal Range | Establish a 5-95% reference range for apparently healthy adult males and females across different age groups. | Determined from 187 adult males (21-75 years) and 188 adult females (21-75 years). |
| Males (pg/mL): |
- 21-30: 47.2 - 136.2
- 31-40: 46.8 - 106.8
- 41-50: 36.5 - 82.7
- 51-60: 19.1 - 89.0
- 61-75: 12.2 - 68.6
Females (pg/mL): - 21-30: 7.9 - 50.4
- 31-40:
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.