(214 days)
Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use.
Free testosterone test is 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 female's hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
The radioimmunoassay of free testosterone is a competitive assay. The procedure follows the basic principle of radioimmunoassay where there is competition between a radioactive and a non-radioactive antigen for a mixed number of antibody binding sites. The amount of [125]]-labeled testosterone analog bound to the antibody is inversely proportional to the concentration of unlabeled free testosterone present. The separation of the free and bound antigen is achieved by decanting or aspirating the antibody-coated tubes. A standard curve is constructed and unknown free testosterone values are obtained from the curve by interpolation.
Kit Content:
Free Testosterone Antibody-Coated Tubes: 2 x 50 tubes (ready-to-use)
125|-labeled Testosterone Analog Tracer (YELLOW): one 22 mL vial (ready-to-use)
Calibrators: one 1.0 mL vial labeled 0, and seven 0.5 mL vials labeled 1-7 (ready-to-use)
Controls: two 0.5 mL vials labeled 1, 2 (ready-to-use)
The provided text describes the Immunotech ACTIV\u00AE Free Testosterone RIA device, a radioimmunoassay for the quantitative measurement of free testosterone in human serum. This is an in vitro diagnostic device and the information provided is a 510(k) summary, which is typically for demonstrating substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" for overall device performance in the form of pass/fail thresholds for clinical utility. Instead, it provides a summary of the analytical performance characteristics and reference ranges, which are the results of validation studies conducted to support the device's claims and demonstrate its performance.
| Performance Characteristic | Acceptance Criteria (Implicit from CLSI guidelines and typical IVD requirements) | Reported Device Performance |
|---|---|---|
| Sensitivity | - Limit of Blank (LoB) |
§ 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.