(161 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (DPC COAT-A-Count Free Testosterone kit) | Correlation (r) = 0.8908 |
| Sensitivity | Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices" |
| Specificity | Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices" |
| Intra-assay precision | Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices" |
| Inter-assay precision | Not explicitly quantified, but stated to reflect "same equivalence as the predicate devices" |
| Same intended use | Yes: "Direct determination of Free Testosterone by enzymeimmunoassay (Elisa) in human serum." |
| Same characteristics (antigen/antibody) | Yes |
| Similar methodology, reagents, materials, control serum | Yes |
Study Details
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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.
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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.
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Adjudication method for the test set:
- Not applicable. This is a quantitative measurement comparison between two devices, not a diagnostic interpretation by multiple readers.
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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.
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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.
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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.
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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.
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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.
§ 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.