(338 days)
Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.Measurements 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) due to tumors, polycystic ovaries, and adrenogenital syndromes.
The Elecsys Testosterone II immunoassay makes use of a competitive test principle using streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2point calibration and master curve provided with the reagent bar code. The Elecsys Testosterone II reagent kit consists of a Reagent Pack (R1, R2, and M (Streptavidin-coated microparticles)).
The Elecsys Testosterone II device is an immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma. The device is intended for use on the cobas e 601 immunoassay analyzer.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Elecsys Testosterone II are based on various analytical performance characteristics. The table below summarizes some of the key performance criteria and the reported performance of the candidate device (Elecsys Testosterone II, K211685) in comparison to its predicate device (Elecsys Testosterone II, K093421).
| Feature | Acceptance Criteria (Predicate) | Reported Performance (Candidate) |
|---|---|---|
| Precision | Refer to CLSI EP05-A | 21-day precision: Evaluated according to CLSI guideline EP05-A3. Protocol: 2 replicates of 2 controls and 5 samples, 2 runs/day over 21 days with 1 reagent lot. Repeatability and intermediate precision calculated. 5-day precision: Evaluated on one cobas e 601 analyzer according to CLSI guideline EP05-A3. Protocol: 5 aliquots of each control (PreciControl Universal Level 1 & 2) and human serum samples per run, 1 run/day for 5 days with 3 lots. Repeatability and intermediate precision calculated. |
| LoB | 1.2 ng/dL | 1.50 ng/dL or 0.052 nmol/L |
| LoD | Same as predicate | 2.50 ng/dL or 0.087 nmol/L |
| LoQ | Same as predicate | 12.0 ng/dL or 0.416 nmol/L |
| Measuring Range | 2.50-1500 ng/dL or 0.087-52.0 nmol/L | 2.50-1500 ng/dL or 0.087-52.0 nmol/L (defined by Limit of Detection and maximum of master curve). |
| Cross-Reactivity | Various specific values | DHEA-S: 0.003%, Androstenedione: 3.15%, Danazol: 0.504%, Estradiol: 0.211%, Ethisterone: 3.57%, 19-Norethisterone: 5.51%, Norgestrel: 0.539%, △5-Androstene-3β17β-diol: 0.289%, Testosterone propionate: 0.718%, 5α-Androstane-3β, 17β-diol: 2.15%, 5α-Dihydrotestosterone: 1.30%, 11β-OH-Testosterone: 20.6%, 11keto-Testosterone: 4.87%, Prednisone: n.d., Prednisolone: n.d., Progesterone: 0.009%, Cortisol: n.d., Cortisone: n.d., Dexamethasone: n.d., Estrone: n.d., DHEA: 0.014%. |
| Biotin Interference |
§ 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.