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The Free Testosterone AccuBind® ELISA Test System is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and in females; hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and androgenital syndromes.

The kit consists of seven (7) vials of serum reference calibrators for Free Testosterone with two (2) controls (one low and one high); one (1) vial of Testosterone (Analog)-horseradish peroxidase (HRP) conjugate in a protein stabilizing matrix; one 96-well testosterone antibody-coated microplate; one (1) vial of concentrated wash solution; two (2) vials for tetramethy(benzidine (TMB) substrate solution preparation; and one (1) vial of stop reaction solution.

The provided document describes the analytical performance of the Monobind Inc. Free Testosterone AccuBind® ELISA Test System, an in vitro diagnostic device, rather than an AI/ML-driven device. Therefore, many of the requested criteria often associated with AI/ML device studies (e.g., number of experts for ground truth, MRMC studies, human-in-the-loop performance, training set details) are not applicable to this type of medical device.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets them as presented in the document.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of in-vitro diagnostic device, "acceptance criteria" are typically defined by regulatory standards and good laboratory practices (e.g., CLSI guidelines). The document presents analytical performance data against these established industry benchmarks rather than explicit numerical acceptance criteria beyond what is internally defined for successful assay development and validation (e.g., precision specifications).

2. Sample Size Used for the Test Set and Data Provenance

• Precision Study:
  • Sample Size: For the representative lot, 3 control samples were tested, with 80 measurements per sample (duplicate, two times per day for 20 days). 3 serum pools were also tested in the same manner (N=32 readings for the representative lot table, N=80 for combined lot table). For the combined lot precision, 3 controls and 3 patient samples (serum pools) were used, with a total of 80 measurements per sample.
  • Data Provenance: Not explicitly stated, but typical for in vitro diagnostic device validation, these would be controlled laboratory studies using clinical samples (serum pools and control materials). No mention of country of origin or retrospective/prospective clinical data for the performance evaluation (this differs from the reference range determination).
• Linearity Study: 11 concentrations of sample preparations.
• Recovery Study: 5 serum samples (containing different levels of endogenous testosterone).
• Reference Range Determination: 261 male and female serum samples.
  • Data Provenance: Not specified for the 261 samples, but typically these samples are collected under ethical guidelines from a relevant population.
• Cross-Reactivity Study: Specific compounds were tested with male serum spiked samples and blank serum spiked samples. No specific number of replicates per compound is given, but "aliquots from pool of human serum" are mentioned for testosterone cypionate and undecanoate.
• Method Comparison Study: 137 samples.
  • Data Provenance: Not explicitly stated, but these would be clinical samples with varying testosterone levels.
• Interferences Study: Charcoal-stripped human serum spiked with known concentrations of interferent.

3. Number of Experts Used to Establish the Ground Truth and Qualifications of Experts

• Not Applicable. For an in-vitro diagnostic assay for quantitative measurement of an analyte like Free Testosterone, the "ground truth" is established by the analytical method itself (the assay's ability to accurately measure the target analyte) and validated against reference methods or calibrated materials. There are no human "experts" establishing image-based ground truth as would be the case for AI/ML diagnostic tools. The predicate device serves as a comparative "ground truth" for method comparison.

4. Adjudication Method for the Test Set

• Not Applicable. This is an in-vitro diagnostic assay, not an AI/ML system requiring human adjudication of results. The results are quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is an in-vitro diagnostic assay, not an imaging AI/ML device that assists human readers. Therefore, an MRMC study is not relevant or performed.

6. Standalone (Algorithm Only) Performance

• Yes (inherently). The device itself is the "standalone" measurement system. Its performance (precision, linearity, recovery, sensitivity, specificity, interference) is evaluated on its own. There isn't a separate "human-in-the-loop" component as would be found in an AI-assisted diagnostic workflow.

7. The Type of Ground Truth Used

The ground truth for this device's performance validation is established through:
* Known Concentrations: For precision (control materials with known values), linearity (prepared concentrations), recovery (spiked samples with known additions), detection limits (analyzing blanks and low-concentration samples).
* Reference Methods/Predicate Device: For method comparison, the predicate device (EiAsy Free Testosterone EIA) serves as the comparator.
* Established Analytical Principles: The fundamental biochemical reactions and measurement principles of the ELISA platform.
* CLSI Guidelines: Adherence to established Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP06-A, C28-A3, EP17-A, EP07-A2) for validation studies provides the framework for defining acceptable performance.

8. The Sample Size for the Training Set

• Not Applicable. This is an in-vitro diagnostic assay, not an AI/ML device that requires a distinct "training set" in the context of machine learning model development. The development and optimization of the assay's reagents and protocol are analogous to "training" in a general sense, but no specific numerical sample size is defined as a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As above, there is no AI/ML "training set." The "ground truth" for developing such an assay comes from fundamental biochemical understanding, chemical synthesis of reagents, and iterative optimization of assay conditions to achieve desired analytical performance characteristics. This involves standard laboratory development practices common to IVD manufacturing.

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The Monobind AccuBind Neo-TSH Microwell Elisa Assay is an in vitro diagnostic test system for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood dried on Whatman 903 filter paper. It is intended to be used to screen newborns for congenital hypothyroidism.

The Monobind AccuBind™ Neonatal TSH Elisa Assay is a solid phase two-site immunoenzymometric assay based on the direct sandwich technique in which two specific antibodies are directed against two separate antigenic determinants on the hTSH molecule. In this method, TSH dried whole blood callbrator, patient specimen or control is first added to a streptavidin coated well. Elution buffer containing biotinylated monoclonal antibodies are added and the reactants mixed. Reaction between the biotinylated Anti-TSH and the TSH in the dried blood spot forms a complex that binds to the streptavidin coated to the inherent affinity of streptavidin and biotin. After the completion of the first incubation period, excess reactants are washed off via a wash step and the enzyme conjugate (another specific anti-TSH antibody linked to an enzyme) is added to the Ag-Ab complex deposited on the plastic surface. The enzyme labeled Anti-TSH antibody binds to the TSH making a sandwich complex with two antibodies bound to the antigen during a second incubation. The microplate is washed to remove unreacted enzyme. Finally, the activity of the enzyme present on the surface of the well is quantitated by reaction with a suitable substrate to produce color.

The provided document describes the Monobind AccuBind Neo-TSH Microwell Elisa Kit, an in vitro diagnostic test system for screening newborns for congenital hypothyroidism by quantitatively determining thyroid stimulating hormone (TSH) in dried whole blood.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for agreement or performance metrics. Instead, it relies on a comparative effectiveness study against a predicate device to demonstrate substantial equivalence. The implicit acceptance criterion is that the new device's performance should be comparable to the predicate device.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 158 newborn samples.
• Data Provenance: The document does not explicitly state the country of origin. It is a retrospective comparison as the samples were measured with both the new device and the existing predicate device.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of experts to establish ground truth. The comparison is made against a legally marketed predicate device, with its results serving as the reference for comparison.

4. Adjudication Method for the Test Set

• None specified. The study compares the measurements of two different assay methods directly. There is no indication of an adjudication process to reconcile discrepancies between the two device readings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. This is an in vitro diagnostic test for measuring TSH levels. The study involves comparing the quantitative results of two different assay kits on a set of samples, not the interpretation of results by human readers. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance was done. The Monobind AccuBind Neo-TSH Microwell Elisa Kit is an in vitro diagnostic test, and its performance (quantitative measurement of TSH) is assessed as a standalone device by comparing its output with that of a predicate device. The results (hTSH concentrations) are directly generated by the assay kit.

7. Type of Ground Truth Used

• The ground truth used is effectively the results obtained from the legally marketed predicate device (Neonatal TSH RIA Kit (I-125) 510(k)# K772192). The study's objective is to show substantial equivalence to this predicate device. This is a form of "reference standard" or "comparator device" ground truth.

8. Sample Size for the Training Set

• The document does not provide information regarding a "training set" or its sample size. This type of device (Elisa kit) typically undergoes analytical validation and clinical validation. While some internal development (which could involve "training" in a broad sense for assay optimization) would have occurred, the document focuses on the premarket notification and equivalence comparison, which uses a test set of 158 samples. It's unlikely that a distinct "training set" as understood in machine learning contexts would be explicitly reported for this type of IVD.

9. How Ground Truth for the Training Set Was Established

• As no training set is discussed or explicitly defined in the document, no information is provided on how its ground truth would have been established.

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