(79 days)
ADVIA Centaur® Testosterone II (TSTII)
The ADVIA Centaur® Testosterone II (TSTI) assav is for in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system.
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.
ADVIA Centaur® SHBG
The ADVIA Centaur® SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system.
The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
The re-standardized ADVIA Centaur® Testosterone II (TSTII) and the ADVIA Centaur® SHBG are in vitro diagnostic immunoassays for use on the ADVIA Centaur® XP system. The ADVIA Centaur® Testosterone II (TSTII) assay quantitatively determines total testosterone in human serum and plasma. The ADVIA Centaur® SHBG assay quantitatively determines sex hormone-binding globulin (SHBG) in human serum and plasma. The submission includes details on the ingredients of the reagents for both assays.
Here's a breakdown of the acceptance criteria and study information for the ADVIA Centaur® Testosterone II (TSTII) and ADVIA Centaur® SHBG based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (ADVIA Centaur® Testosterone II (TSTII)) | Reported Device Performance (ADVIA Centaur® Testosterone II (TSTII)) | Acceptance Criteria (ADVIA Centaur® SHBG) | Reported Device Performance (ADVIA Centaur® SHBG) |
|---|---|---|---|---|
| Detection Limits | ||||
| Limit of Blank (LoB) | (Implicitly good performance relative to predicate) | 2.50 ng/dL | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Limit of Detection (LoD) | (Implicitly good performance relative to predicate) | 5.00 ng/dL (95% probability) | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Limit of Quantitation (LoQ) | (Total CV of 20%) | 7.00 ng/dL (at 20% CV) | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Precision | (Implicitly good performance relative to predicate) | See table below for detailed CVs across various samples and concentrations. Generally, Within-Run CVs are lower than Within-Lab CVs. | (Not explicitly provided in this document) | (Previously established, see K151986 & K091867) |
| Linearity | Bias from linear fit estimate |
§ 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.