(83 days)
VIDAS Testosterone is an automated test for use on the VIDAS analyzer for the enzyme immunoassay measure of total testosterone in human serum or plasma (heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the disgnosis and management of conditions involving excess or deficiency of this androgen.
The VIDAS Testosterone (TES) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS instrument. All assay steps and assay temperatures are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are in the sealed TES Reagent Strips.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VIDAS Testosterone (TES) Assay:
Acceptance Criteria and Device Performance for VIDAS Testosterone (TES) Assay
This document details the performance of the VIDAS Testosterone (TES) Assay, an enzyme-linked fluorescent immunoassay (ELFA), and the studies conducted to demonstrate its substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a table format with pass/fail values. Instead, the document presents performance parameters and compares them to predicate devices or general analytical quality criteria. The table below synthesizes the reported performance against implied or general acceptance for in vitro diagnostic assays.
| Performance Characteristic | Acceptance Criteria (Implied/General) | Reported VIDAS TES Assay Performance |
|---|---|---|
| Specificity | Minimal cross-reactivity with similar compounds and no significant interference from common sample contaminants. | Tested Compounds: Testosterone (100.00%), 19-Nortestosterone (6.4%), 5α-dihydrotestosterone (0.98%), Δ4-androstenedione (0.07%), etc. (see table in source document) |
| Interference: No significant interference from Heparin, Bilirubin, Hemoglobin, Triglycerides. Note: EDTA leads to increased testosterone, so EDTA plasma must not be used. | ||
| Limit of Detection | Low enough to detect clinically relevant concentrations. | 0.1 ng/mL |
| Intra-Run Precision (CV%) | Typically 0.9). | Slope: 1.0602, Ordinate: -0.137, Correlation Coefficient: 0.9660 (R-value) |
| Correlation with Reference Method (ID-GCMS) | Strong correlation (e.g., R-value > 0.9), potentially better than predicate. | Y(VIDAS TES) = 0.944 X (ID-GCMS) + 0.1452, R² = 0.8989, R = 0.94 |
| Correlation with Expert Tested Kit (TESTO CT2) | Good correlation with a clinically accepted kit. | R² = 0.8106 |
| Expected Values | Established reference ranges for healthy populations. | Provided for healthy males/females. |
Conclusion on Acceptance: The reported performance metrics for specificity, limit of detection, precision, linearity, recovery, and correlation with both predicate and reference methods strongly suggest that the VIDAS Testosterone (TES) Assay meets the necessary analytical quality criteria for its intended use, as affirmed in the conclusion statement.
2. Sample Size Used for the Test Set and Data Provenance
- Correlation with DPC Coat-A-Count: 216 samples.
- Correlation with TESTO CT2: 183 serum samples.
- Correlation with ID-GCMS: 13 sera.
- Dilution Study: 3 sera collected from patients.
- Recovery Test: 3 plasma samples.
The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The adjudication method is not specified in the provided text. The studies primarily involve quantitative comparisons to reference methods and predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this device is an in vitro diagnostic assay (automated immunoassay) and does not involve human readers interpreting results in the same way an imaging or pathology device would. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. Standalone Performance Study
Yes, a standalone performance study was done. The entire document describes the standalone performance of the VIDAS TES Assay, a fully automated algorithm (ELFA technique) without human intervention in the result generation process. The correlation with the reference method (ID-GCMS) directly demonstrates the algorithm's standalone accuracy.
7. Type of Ground Truth Used
- For correlation and accuracy assessment:
- Reference Method: Isotope Dilution-Gas Chromatography/Mass Spectrometry (ID-GCMS) was used as a reference method for 13 samples. ID-GCMS is widely considered a highly accurate and precise "gold standard" method for testosterone measurement.
- Predicate Devices: The DPC Coat-A-Count Total Testosterone assay and the CIBA Corning ACS Testosterone Immunoassay were used for comparison, representing legally marketed and established methods.
- Expert Tested Kit: The TESTO CT2 Kit (Cis Bio International) was also used for comparative analysis.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. Immunoassays are typically developed and validated using a different paradigm than AI/machine learning algorithms. While there is assay development and optimization, it's not described as a distinct "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established
Since a distinct training set (at least as described for AI/ML) is not mentioned, the method for establishing its ground truth is not applicable or not specified. The product development process for an immunoassay generally involves extensive analytical validation using samples with known concentrations (often established by reference methods or gravimetric preparation) to optimize assay parameters and ensure performance characteristics.
§ 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.