(50 days)
This in vitro method is intended to quantitatively measure testosterone in human servin on a Technicon Immuno 1 system. Measurements of Testosterone are used in the diagnosis and treatment of various hormonal sexual disorders.
This document describes the Immuno 1 Testosterone method, an in vitro method for quantitatively measuring testosterone in human serum on a Technicon Immuno 1 system. It compares the performance of this method to a predicate device, the DPC Coat-a-Count Total Testosterone RJA kit, in terms of minimum detection concentration, precision, and correlation. It also provides a specificity comparison by listing the crossreactivity percentages of various substances with both methods.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bayer Immuno 1 Testosterone Method:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from predicate device/comparison) | Immuno 1 Testosterone Method Performance | Acceptance Met? |
|---|---|---|---|
| Minimum Detection Concentration | 0.04 ng/mL (DPC predicate) | 0.04 ng/mL | Yes |
| Precision (Between-Run) | 0.93 ng/mL: 12% | ||
| 2.64 ng/mL: 6.4% | |||
| 6.72 ng/mL: 6.0% (DPC predicate) | 0.86 ng/mL: 6.3% | ||
| 3.13 ng/mL: 3.5% | |||
| 8.58 ng/mL: 2.2% | Yes (Immuno 1 shows equal or better precision across all levels) | ||
| Correlation with Predicate Device (DPC) | Implicitly, a strong linear correlation with the DPC Coat-a-Count Total Testosterone RJA kit | y = 0.98x + 0.01 | |
| n = 335 | |||
| r = 0.990 | |||
| S = 0.41 ng/mL | Yes (Very strong correlation, indicating agreement) | ||
| Specificity (Cross-reactivity - examples) | Aldosterone: 0% | ||
| Androstenedione: 0.5% | |||
| 5α-Dihydrotestosterone: 3.3% | |||
| 19-Nortestosterone: 20% | |||
| 11β-Hydroxytestosterone: 0.8% (DPC predicate) | Aldosterone: ND (None Detected) | ||
| Androstenedione: 0.4% | |||
| 5α-Dihydrotestosterone: 4.7% | |||
| 19-Nortestosterone: 7.6% | |||
| 11β-Hydroxytestosterone: 14.2% | Generally consistent or improved for many, some differences noted (e.g., 5α-Dihydrotestosterone higher, 19-Nortestosterone lower for Immuno 1). The overall intent is to show comparable specificity, which appears to be met given the wide range of cross-reactants examined. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 335 samples were used for the correlation study comparing the Immuno 1 method to the DPC predicate device.
- Data Provenance: Not explicitly stated. The document does not mention the country of origin of the samples or whether they were retrospective or prospective. It only mentions "human serum."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a comparison study between two in vitro diagnostic devices, not a study involving human interpretation of images or data. Therefore, the concept of "experts establishing ground truth" in the typical sense (e.g., radiologists reviewing scans) is not applicable here. The ground truth for the Immuno 1 device is implicitly established by its correlation with a predicate device (DPC Coat-a-Count Total Testosterone RJA kit), which itself is an established and cleared diagnostic method.
4. Adjudication Method for the Test Set
Not applicable. This is a direct comparison of quantitative measurements from two analytical instruments, not a subjective assessment requiring adjudication.
5. 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
Not applicable. This study concerns the performance of an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is effectively a standalone performance study of the Immuno 1 Testosterone method. It evaluates the device's analytical performance (minimum detection, precision, correlation, specificity) independent of human interpretation or interaction beyond standard laboratory procedures for running the assay.
7. The Type of Ground Truth Used
The "ground truth" for the Immuno 1 Testosterone method in this submission is the results obtained from the DPC Coat-a-Count Total Testosterone RJA kit (predicate device). The study's goal is to demonstrate substantial equivalence by showing that the Immuno 1 method produces comparable results to a legally marketed and accepted device.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable in this context. This is a clinical validation study for an in vitro diagnostic device, not a machine learning algorithm that requires training data. The device's internal calibration and optimization would have occurred during its development, but the document does not provide details on that "training" process.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" with established ground truth is not relevant to this type of device and study as presented. The device is validated against an established predicate, and its internal mechanisms are based on biochemical principles rather than trained on data.
§ 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.