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The dbc CAN-fTE-260 EiAsy™ Free Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Free Testosterone in human serum. This assay is intended for in vitro diagnostic use only. Measurement of Free Testosterone are used in the diagnosis in male sex hormones (androgens) and in females hirsutism (excessive hair) and virilisation (masculinization).

The free Testosterone 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 in human serum matrix and all other reagents within the kit namely assay buffer, wash buffer concentrate, substrate tetramet hytbenzidine (TMB) and stopping solution. 50 ul of patient serum , control serum and each standard are added to each well. 100 ul of conjugate solution is again added to each well. The incubation time is 37°C for 60 minutes. After incubation the plates are washed 3 times, each time with 300 ul of diluted wash buffer. The plates are dried. 100 ul of substrate TMB is added to each well and allowed to incubate for 10 - 15 minutes at 37°C. 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 nm.

Here's an analysis of the provided text to extract the acceptance criteria and study information:

The document describes the dbc Free Testosterone by Enzymeimmunoassay (EiA) device and its comparison to a predicate device, the Diagnostics Products Corporation (DPC) COAT-A-Count Free Testosterone kit.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it focuses on demonstrating substantial equivalence to the predicate device. The primary performance metric presented is the correlation coefficient (r) between the new device and the predicate device.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 61 human serum samples.
   • Data Provenance: Not explicitly stated (e.g., country of origin). It is a retrospective comparison as the samples were tested on both devices to demonstrate equivalence.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for this type of device (in-vitro diagnostic assay for a biomarker). The "ground truth" is established by the predicate device's measurement. There's no mention of expert review of the results in the context of establishing ground truth.

3. Adjudication method for the test set:

   • Not applicable. This is a quantitative measurement comparison between two devices, not a diagnostic interpretation by multiple readers.

4. 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:

   • No. This is an immunoassay kit, not an AI-powered diagnostic imaging device involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, implicitly. The performance data (correlation, sensitivity, specificity, precision) refer to the standalone performance of the dbc EiA kit compared to the predicate device. As an in-vitro diagnostic, it operates as a standalone measurement tool.

6. The type of ground truth used:

   • Predicate device comparison: The performance is established by comparing the results of the new device to those obtained from a legally marketed and established predicate device (DPC COAT-A-Count Free Testosterone kit). The predicate device's measurements serve as the reference for "ground truth" in demonstrating equivalence.

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning or AI. For an immunoassay, the development and optimization (which could be considered analogous to training) would involve optimizing reagents, protocols, and validating against known standards or reference materials. This document focuses on the validation against the predicate device.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set in the AI sense. Ground truth for immunoassay development (if one were to use the term) would typically involve NIST (National Institute of Standards and Technology) traceable reference materials, reference methods (e.g., mass spectrometry), or highly characterized patient samples where the analyte concentration is known through established techniques. This information is not detailed in the provided text.

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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.

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.

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