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510(k) Data Aggregation
(82 days)
AxSYM® Testosterone is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System.
Testosterone monitoring is used clinically to diagnose and differentiate endocrine disorders. In males, these include hypogonadism, testicular failure, infertility, hypopituitarism and hyperprolactinemia. In females, polycystic ovary syndrome, adrenal hyperplasia, infertility, hirsutism, amenorrhea, obesity and virilization can cause changes in serum testosterone levels.
The AxSYM® Testosterone assay is used as an aid in the investigation of infertility in males and of hirsutism and virilization in females.
The AxSYM® Testosterone Standard Calibrators are for the standard calibration of the AxSYM system when used for the quantitative determination of testosterone in human serum and plasma.
Competition format. Microparticle Enzyme Immunoassay (MEIA) for use on Abbott AxSYM® system.
Assay procedure:
- Incubate the sample with the antibody-coated microparticles.
- Add testosterone alkaline phosphatase conjugate and incubate.
- Transfer to matrix cell.
- Wash to remove unbound substances.
- Add substrate.
- Measure fluorescent product.
Acceptance Criteria and Device Performance Study for AxSYM® Testosterone MEIA
This document describes the acceptance criteria and the supporting study for the AxSYM® Testosterone Microparticle Enzyme Immunoassay (MEIA) device, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document compares the AxSYM® Testosterone immunoassay (Submission Device) to the Roche Elecsys® Testosterone assay (Predicate Device). The acceptance criteria are implicitly defined by the reported performance of the predicate device and the new device's performance demonstrating substantial equivalence. Given the nature of a 510(k) equivalency claim, the "acceptance criteria" for the new device are typically that its performance characteristics are comparable or superior to the predicate device within clinically acceptable ranges.
| Parameter | Acceptance Criteria (Implied by Predicate Device Performance) | Reported Device Performance (AxSYM® Testosterone) |
|---|---|---|
| Precision | Within-run CV of 0.9% to 4.6% Total CV of 1.6% to 7.4% (from 0.24 to 7.01 ng/mL) | Within-run CV of 3.9% to 8.3% Total CV of $\le$ 14% for samples with testosterone concentrations $\ge$ 0.85ng/ml and $\le$ 10% for samples $\ge$ 2.10ng/ml. |
| Functional Sensitivity | Not stated (for predicate device) | $\le$ 0.2ng/ml |
| Analytical Sensitivity | 0.02ng/ml | $\le$ 0.1ng/ml |
| Analytical Specificity | Cross-reactivity ranged from 0-10.4% for 12 potential cross-reactants tested at 40ng/mL. | <1% cross reactivity observed (for 25 potential cross-reactants, dependent on cross-reactant; concentrations stated in pack leaflet). |
| Interfering Substances | No interference at: Bilirubin - 25mg/dL Haemoglobin - 1.0g/dL Lipemia - 1500mg/dL Biotin - 30ng/mL | <15% interference at: Bilirubin - 20mg/dL Haemoglobin - 750mg/dL Protein - 10g/dL Triglycerides - 500mg/dL SHBG - 90nmol/L |
Note: For a 510(k) submission, "acceptance criteria" are often fulfilled by demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must perform as safely and effectively as the predicate, even if the specific numerical values differ slightly. The provided summary focuses on demonstrating this equivalence rather than explicit acceptance "thresholds" beyond the predicate's performance.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the performance characteristics presented. It only summarizes the results obtained from various analytical studies.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided in the 510(k) summary. For in vitro diagnostic devices like this testosterone assay, clinical "ground truth" for individual patient samples would typically be established through reference methods (e.g., ID-GCMS for standardization) or clinical diagnosis by healthcare professionals. The summary mentions that "Concentration is standardised gravimetrically and confirmed by GCMS (Gas Chromatography Mass Spectrometry)" and "The method has been standardised via ID-GCMS (Isotope Dilution Gas Chromatography Mass Spectrometry)" for the predicate. These are analytical reference methods, not clinical expert consensus.
4. Adjudication Method for the Test Set
The 510(k) summary does not provide information regarding any adjudication methods for establishing ground truth for the test set, as it focuses on analytical performance characteristics rather than clinical outcome studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases with and without AI assistance to measure the AI's impact on human performance. The AxSYM® Testosterone MEIA is an automated in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation device that would typically involve human readers in that manner.
6. Standalone Performance Study
A standalone study of the algorithm's (i.e., the MEIA assay's) performance was done. The entire "Performance Characteristics" section in the comparison table details the standalone performance of the AxSYM® Testosterone MEIA, including its precision, functional sensitivity, analytical sensitivity, analytical specificity, and interference by various substances. This data directly reports the algorithm's (assay's) performance without human intervention beyond routine operational procedures.
7. Type of Ground Truth Used
The "ground truth" for the performance characteristics is established through a combination of:
- Reference Methods: Concentration standardization is stated to be done gravimetrically and confirmed by GCMS (Gas Chromatography Mass Spectrometry) or ID-GCMS (Isotope Dilution Gas Chromatography Mass Spectrometry). These are highly accurate analytical methods used to define true analyte concentrations.
- Controlled Experiments: For parameters like analytical specificity and interfering substances, experiments are conducted by adding known concentrations of potential cross-reactants or interferents to samples with known testosterone levels and measuring the device's response.
- Internal Validation Studies: For precision, repeated measurements of samples are taken to assess the variability of the device.
8. Sample Size for the Training Set
The 510(k) summary does not specify the sample size for the training set. For an immunoassay like this, the "training set" would refer to the samples and data used during the development and optimization phases of the assay to establish parameters like reagent concentrations, incubation times, and calibration curve algorithms. This information is typically proprietary development data and is not usually detailed in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
The 510(k) summary does not explicitly state how the ground truth for the training set was established. However, given the nature of in vitro diagnostic assay development, it would have been established through a rigorous process involving:
- Reference Standards: Use of highly pure, accurately weighed testosterone standards.
- Reference Methods: Likely GCMS or ID-GCMS for initial calibration and validation of reference materials.
- Spiking Studies: Adding known amounts of testosterone to matrices (e.g., serum, plasma) to create samples with defined concentrations.
- Method Optimization: Iterative testing and adjustment of assay components and protocols using these known samples to achieve desired performance characteristics (e.g., sensitivity, linearity, precision) before final validation.
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