(135 days)
The DiaSorin LIAISON® Testosterone assay is a direct, competitive, chemiluminescence immunoassay (CLIA) intended for the quantitative determination of testosterone in human serum and plasma on the LIAISON®Analyzer. The assay is intended for in vitro diagnostic use.
Measurement of testosterone 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 male subjects and, in female subjects hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
The DiaSorin LIAISON® Testosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® Testosterone immunoassay.
The LIAISON® Testosterone assay's method for quantitative determination of testosterone is a direct, competitive, chemiluminescence immunoassay (CLIA). Specific antibody to testosterone is bound to magnetic particles (solid phase) and testosterone is linked to an isoluminol derivative. During the incubation, testosterone is dissociated from its binding protein and competes with labeled testosterone for binding sites on the antibody. After the incubation, the unbound material is removed with a wash cycle, Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of testosterone present in calibrators, controls, or samples. All assay steps and incubations are performed by the LIAISON® Analvzer.
Two point kit calibrators are used to establish specific working curves based on assay master curves stored on the Analyzer.
The LIAISON® Testosterone reagent kit consists of a reagent intrgral which contains antibody coated magnetic particles (2.3 mL), conjugate (12 mL) and assay buffer (12 mL) reagents. Two levels of ready to use calibrators (2 vials each level, 2.0 mL per vial) are provided with each kit. Each kit consists of 100 tests.
The DiaSorin LIAISON® Testosterone assay and Control Set are subject to a 510(k) premarket notification for substantial equivalence to a predicate device. This submission outlines performance data to demonstrate that the device meets acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate, defined set of thresholds for each performance metric, but rather presents the results of various studies and compares them to the predicate device and established guidelines (e.g., CLSI guidelines). The performance data implicitly serves as the evidence that the device meets the necessary standards for its intended use.
Here's a summary of the reported device performance:
| Performance Metric | Reported Device Performance (LIAISON® Testosterone) | Implicit Acceptance Criteria (based on predicate and guidelines) |
|---|---|---|
| Method Comparison | Passing & Bablok linear regression: y = 0.9458x - 0.1002, R = 0.990. 95% CI for slope: 0.92 to 0.96. 95% CI for intercept: -1.88 to 1.80 ng/dL. | Strong correlation (R-value close to 1) and good agreement in results with the predicate device (slope close to 1, intercept close to 0) in accordance with CLSI EP9-A2 guidelines. |
| LoB | ≤ 3.1 ng/dL | Determined according to CLSI EP17-A. Represents the lowest analyte concentration likely to be reported as greater than zero. |
| LoD | 9.8 ng/dL | Determined according to CLSI EP17-A. Represents the lowest analyte concentration detectable with reasonable statistical certainty. |
| LoQ | 16.0 ng/dL | Determined according to CLSI EP17-A. Represents the lowest analyte concentration at which the assay provides acceptable accuracy and precision. |
| Measuring Range | 16.0 - 1500 ng/dL (Also mentioned in comparison to predicate: 16.0 - 1500 ng/dL vs. 2.5 - 1500 ng/dL for Roche Cobas®) | Demonstrated capability to accurately and precisely quantify testosterone within this range, clinically relevant to the intended use. Similar to or better than predicate where appropriate. |
| Reproducibility/Precision | Within Run %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.