(302 days)
Reagents: The ARCHITECT® SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT i System. The ARCHITECT SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
Calibrators: The ARCHITECT® SHBG Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma.
Controls: ARCHITECT® SHBG Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma. For in vitro diagnostic use.
The ARCHITECT SHBG assay is a two-step immunoassay to determine the presence of SHBG in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-SHBG coated paramagnetic microparticles are combined. SHBG present in the sample binds to anti-SHBG coated microparticles. After washing, the SHBG binds to the anti-SHBG acridinium-labeled conjugate that is added in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of SHBG in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of SHBG in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT SHBG calibration.
The ARCHITECT® SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma. The study conducted to demonstrate its substantial equivalence compared its performance against the Elecsys® SHBG Immunoassay System (Roche, k#031717).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes characteristics that are evaluated for substantial equivalence. The key performance indicator for the assay itself is the correlation coefficient for method comparison.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported ARCHITECT® SHBG Performance |
|---|---|---|
| Method Comparison (Correlation Coefficient) | High correlation (e.g., typically >0.95 for quantitative assays in IVD) | 0.98 |
| Precision | Substantially equivalent to predicate | Substantially Equivalent |
| Linearity | Substantially equivalent to predicate | Substantially Equivalent |
| Interferences | Substantially equivalent to predicate | Substantially Equivalent |
| Measuring Range | Comparable to predicate (0.1 – 250 nmol/L for device vs 0.350 - 200 nmol/L for predicate) | 0.1 – 250 nmol/L |
| Analytical Sensitivity | Comparable to predicate (0.1 nmol/L for device vs 0.35 nmol/L for predicate) | 0.1 nmol/L |
| Analytical Specificity | No detectable cross-reactivities with specified substances | No detectable cross-reactivities |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 626 specimens
- Data Provenance: Not explicitly stated, but clinical studies for such devices typically involve prospective or retrospectively collected human samples. The document does not specify the country of origin. Given the applicant is in Spain, it's plausible the data originates from Europe, but this is an inference.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. For an immunoassay like this, the "ground truth" would typically refer to the reference values or results obtained from a well-established and validated reference method (the predicate device in this case, Elecsys® SHBG). It doesn't involve the interpretation of images or other subjective assessments that would require a panel of human experts in the same way an imaging AI might.
4. Adjudication Method for the Test Set:
Not applicable. The ground truth for this type of quantitative assay is established by comparison to a reference method (the predicate device), not through human adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. An MRMC study is not relevant for this type of in vitro diagnostic device. MRMC studies are typically used for evaluating diagnostic imaging systems where human readers interpret medical images, and the AI's role is to assist these readers. This device is a quantitative blood assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, implicitly. The method comparison study is a standalone performance evaluation of the ARCHITECT® SHBG assay algorithm (the device) against the predicate device. The results (e.g., correlation coefficient) represent the performance of the ARCHITECT® SHBG system on its own. Human intervention during the assay process is for operation of the instrument, not for interpretation of the result in a way that significantly influences the quantitative outcome.
7. The Type of Ground Truth Used:
The ground truth used was comparison to a legally marketed predicate device (Elecsys® SHBG Immunoassay System). The predicate device's results serve as the reference standard against which the new device's performance is measured.
8. The Sample Size for the Training Set:
This information is not provided in the document. For an immunoassay, the "training set" concept is usually applied to the development and optimization phase of the assay (e.g., reagent concentrations, reaction times), rather than a distinct, retrospectively defined data set for algorithm training as seen in machine learning. The document focuses on the validation of the finalized assay.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is generally not applicable in the same way as it would be for an AI algorithm that learns from data. For a traditional immunoassay, the "ground truth" during development would be established through meticulous analytical validation using known standards, spiked samples, and comparison to established reference methods to ensure the assay accurately reflects the analyte's concentration.
§ 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.