(248 days)
ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay.
The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The provided text describes the performance characteristics of the ST AIA-PACK SHBG device, which is an in vitro diagnostic assay for measuring Sex Hormone Binding Globulin (SHBG). The studies conducted for this device do not involve AI or human readers for image interpretation, but rather focus on analytical performance criteria typical for a laboratory diagnostic assay. Therefore, questions related to AI assistance, human reader improvement, and adjudication methods are not applicable.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For analytical devices like the ST AIA-PACK SHBG, acceptance criteria are typically specified in terms of performance metrics like precision (CV%), linearity (measuring range), limit of detection (LoD), and correlation with a predicate device. The document generally presents the performance metrics achieved by the device without explicitly stating pre-defined "acceptance criteria" numerical targets. However, comparisons to the predicate device and CLSI guidelines serve as implicit benchmarks for acceptability.
| Performance Characteristic | Implicit Acceptance Criteria (based on CLSI guidelines/predicate comparison/industry standards) | Reported Device Performance (ST AIA-PACK SHBG) |
|---|---|---|
| Precision (Total Precision CV%) | Typically 0.95, slope near 1, intercept near 0). | Deming Slope: 0.949 (0.926 to 0.972), Intercept: -0.64 (-2.61 to 1.34), Corr Coef (R): 0.991. These values demonstrate excellent correlation with the predicate. |
| Matrix Comparison (Serum vs. Plasma) | High correlation between different sample matrices. | Deming Slope: 0.977 (0.964 to 0.991), Intercept: 0.269 (-0.629 to 1.168), Corr Coef (R): 0.997. These values demonstrate excellent correlation between serum and Na heparinized plasma. |
| Interference | No significant interference from common interfering substances (e.g., hemoglobin, bilirubin, lipids, HAMA). Recovery typically within +/-10%. | No interference observed from: Hemoglobin (up to 446 mg/dL), free and conjugated bilirubin (up to 17.6 mg/dL and 18.5 mg/dL respectively), lipemia (triglycerides up to 1,667 mg/dL), ascorbic acid (up to 20 mg/dL), protein (albumin up to 5.00 g/dL), Na Heparin (up to 100.0 U/mL), Rheumatoid factor (up to 550 IU/mL), HAMA (up to 24,269 ng/mL). This meets the non-interference expectation. |
| Cross-Reactivity | Minimal to no cross-reactivity with related or common substances. | Generally N.D. (not detectable) or very low percentage (e.g., 0.003% for Cortisol, 0.019% for Testosterone). Thyroglobulin had a 2.544% cross-reactivity, which may be noted but specific acceptance for such levels is not provided. |
| Calibrator Stability (Real Time) | Recovery within 100 +/- 10%; Reproducibility (CV%) |
§ 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.