(53 days)
The dbc CAN-TE-250 EiAsy™ Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Testosterone in human serum The use of this assay is intended for in vitro diagnostic use only. Measurement of Testosterone are used in the diagnosis and treatment of disorders involving the male sex hormone (androgens), including primary and secondary hypogonadism, delayed or precocious puberty impotence in male and in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrenogenital syndromes.
The Testosterone (total) Elisa kit consists of one polyclonal antibody which is coated on microtiter plate (96 wells per kit). The antigen Testosterone 3 carboxymethyl oxime is conjugated to an enzyme namely horse radish peroxidase. The standards are prepared from protein base matrix and all other reagents within a kit namely assay buffer, wash buffer concentrate, substrate tetramethetbenzidine (TMB) and stopping solution. The incubation time is 60 minutes at room temperature. 25 ul of patient serum , control serum and each standard are added for each assay. After incubation the plates are washed 3 times, each time with 300 ul of diluted wash buffer. The plates are dried. 150 ul of TMB is added to each well and allowed to incubate for 10 - 15 minutes. 50 ul of stopping solution is added into each well and the colour becomes yellow. The plate is read within 20 minutes in a microtiter plate reader at 450 mm.
This document describes the dbc EiAsy™ Testosterone EiA kit, an enzyme immunoassay for determining total testosterone in human serum. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the DSL 10-4000 Active™ Testosterone Enzymeimmunoassay (EiA) kit (510(K) #971823).
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it relies on demonstrating "substantial equivalency" to a predicate device. The performance characteristics are compared to those of the predicate device, implying that performance comparable to the predicate is the acceptance criterion.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (dbc EiAsy™ Testosterone EiA) |
|---|---|---|
| Correlation | Strong correlation with predicate device (e.g., r = 0.958) | r = 0.958 (compared to predicate device) |
| Sensitivity | Comparable to predicate device | Data provided in "results of performance characteristics" (not explicitly stated in summary) |
| Specificity | Comparable to predicate device | Data provided in "results of performance characteristics" (not explicitly stated in summary) |
| Intra-assay Precision | Comparable to predicate device | Data provided in "results of performance characteristics" (not explicitly stated in summary) |
| Inter-assay Precision | Comparable to predicate device | Data provided in "results of performance characteristics" (not explicitly stated in summary) |
| Recovery | Comparable to predicate device | Data provided in "results of performance characteristics" (not explicitly stated in summary) |
| Linearity | Comparable to predicate device | Data provided in "results of performance characteristics" (not explicitly stated in summary) |
Note: The document states that "The results need not be exactly the same but a collaboration of equivalence is necessary in this case r=0.958." This implies that a correlation coefficient of 0.958 was deemed sufficient for demonstrating equivalence in terms of overall agreement between the new device and the predicate. The actual numerical values for most performance characteristics are not provided in this summary but are referenced as being available in the "results of performance characteristics."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "the results of a number of human serum samples." It does not specify the exact number of samples used in the comparison study for the test set.
- Data Provenance: The samples are described as "human serum samples." The country of origin is not explicitly stated. The study appears to be retrospective, as it's a comparison of a newly developed device against an existing, legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of immunoassay device does not typically rely on expert human interpretation to establish a ground truth for its measurements in the same way an imaging diagnostic might. The "ground truth" for evaluating the dbc EiAsy™ Testosterone EiA kit is established by comparing its quantitative testosterone measurements against those obtained from the predicate device. Therefore, the concept of "experts" establishing a ground truth for individual cases is not directly applicable here. The predicate device's measurements serve as the reference.
4. Adjudication Method for the Test Set
Not applicable. As described above, the comparison is directly quantitative against the predicate device; there is no need for expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assesses the impact of AI assistance on human performance. This device is a quantitative in-vitro diagnostic test, not an interpretive one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary study described is a standalone performance evaluation of the dbc EiAsy™ Testosterone EiA kit. Its performance (sensitivity, specificity, precision, recovery, linearity, and correlation) is assessed independently and then compared to the predicate device to establish substantial equivalence. Human involvement is limited to performing the assay according to the protocol, not in interpreting the results beyond reading the optical density.
7. The Type of Ground Truth Used
The "ground truth" used for comparison in this substantial equivalence determination is the measurements obtained from the predicate device, the DSL 10-4000 Active™ Testosterone Enzymeimmunoassay (EiA) kit. The assumption is that the predicate device provides accurate testosterone measurements.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" size. For an immunoassay, the concept of a "training set" as understood in machine learning (where an algorithm learns from labeled data) is not directly applicable in the same way. The development of the assay (e.g., antibody selection, reagent formulation, optimization of incubation times) involves extensive laboratory work and validation but typically doesn't refer to a distinct "training set" in the context of an FDA submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable in the machine learning sense. The "ground truth" for the development and optimization of the immunoassay itself would be based on established analytical chemistry principles, known concentrations of testosterone standards, and comparisons against reference methods during internal development. This is not detailed in the provided 510(k) summary.
§ 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.