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510(k) Data Aggregation
(102 days)
ELECSYS TESTOSTERONE ASSAY
Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma.
Competition principle. Total duration of assay: 18 minutes.
1st incubation (9 min.): 50 µL of sample is incubated with a testosterone-specific biotinylated antibody (55uL) and a testosterone derivative labeled with a ruthenium complex (55 uL) The binding sites of the labeled antibody become occupied partly by the sample analyte (depending on its concentration) and partly by the ruthenium-labeled hapten to form the respective immunocomplexes.
2nd incubation (9 min.): After addition of streptavidin-coated microparticles (40 uL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.
The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
The provided text describes the Elecsys® Testosterone Assay and compares its performance characteristics to a predicate device, the Coat-A-Count® Total Testosterone Assay. The information focuses on analytical performance criteria rather than a clinical study with human readers or ground truth established by experts.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" but rather presents "Performance Characteristics" for the Elecsys® Testosterone Assay. I will interpret the reported values as the device's performance against implicit industry standards or those set by the predicate device.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Elecsys® Testosterone) |
|---|---|---|
| Precision | Comparable to predicate and within acceptable analytical variation | Within-Run %CV: Low: 4.62%, Mid: 1.39%, High: 1.09% |
| Total %CV: Low: 7.41%, Mid: 2.21%, High: 1.68% | ||
| Lower Detection Limit | As low or lower than predicate device, clinically relevant | 0.02 ng/mL |
| Linearity | Clinically useful range with minimal deviation | 0.02-15.00 ng/mL (with a deviation from a linear line of ±10%) |
| Method Comparison (vs. RIA) | Strong correlation (high 'r' value), low SEE, and a slope/intercept close to 1/0, respectively | Least Squares: y = 0.956x + 0.049, r = 0.963, SEE = 0.459, N = 71 |
| Passing/Bablok: y = 1.02x - 0.108, r = 0.963, SEE = 0.349, N = 71 | ||
| Interfering Substances | No significant interference at specified concentrations for common interferents | No interference at: Bilirubin 25 mg/dL, Hemoglobin 1.0 g/dL, Lipemia 1500 mg/dL, Biotin 30 ng/mL |
| Specificity (%Cross-reactivity) | Low cross-reactivity for structurally similar compounds | Varied, with some compounds showing higher cross-reactivity than others (e.g., 11-Ketotestosterone 10.4%, but many others much lower) |
2. Sample size used for the test set and the data provenance
The document does not explicitly define a "test set" in the context of a clinical study. The sample sizes reported are for the analytical performance characteristics:
- Precision: N=60 for each level (low, mid, high) for both within-run and total precision.
- Method Comparison: N=71 for the comparison against RIA.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is an immunoassay for quantitative determination of testosterone, and its performance is evaluated through analytical methods (precision, linearity, method comparison with a reference method) rather than through a ground truth established by human experts interpreting results.
4. Adjudication method for the test set
This information is not applicable for this type of analytical device performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is an automated immunoassay, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The described performance is inherent to the standalone device (the Elecsys® Testosterone Assay) because it is an automated immunoassay system. There is no human-in-the-loop performance component being evaluated in the reported studies, as it is a quantitative measurement device.
7. The type of ground truth used
The "ground truth" for the method comparison was a reference method, specifically RIA (Radioimmunoassay) for Testosterone. The performance characteristics such as precision and linearity are assessed against the device's own measurements and known standards.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning or AI. The term "training set" is not relevant to an immunoassay like the Elecsys® Testosterone Assay.
9. How the ground truth for the training set was established
This information is not applicable.
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