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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 used as an aid in the diagnosis of androgen disorders.

The ARCHITECT SHBG assay is a two-step immunoassay to determine the presence of SHBG in human serum and plasma using chemiluminescent microparticle immunoassay (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, pre-trigger 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.

This document is primarily a 510(k) summary for a labeling change to the ARCHITECT SHBG assay. It is not about a new device or an AI/ML device, but rather an update to the "Free Testosterone Index (FTI) / Free Androgen Index (FAI)" expected values section of the existing device's labeling. Therefore, many of the requested categories for acceptance criteria and study details for AI/ML devices are not applicable.

Here's an interpretation based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device itself (ARCHITECT SHBG assay) was previously cleared. The current submission is for a labeling change to update expected values for the Free Testosterone Index (FTI) or Free Androgen Index (FAI). Therefore, there are no new performance acceptance criteria for the device itself as part of this submission. The performance of the underlying assay remains as established in K060818.

However, the "study" described in the document is the generation of new FTI/FAI expected values. The implicit acceptance criterion for this study is that the calculated FTI/FAI values are representative of the studied populations and are suitable for inclusion in the device labeling. The "reported device performance" in this context refers to the generated expected value ranges.

SHBG Expected Values (nmol/L)

Testosterone Expected Values

% FTI or % FAI Expected Values

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

• Sample sizes:
  • Males (21-49 years of age): 163 samples
  • Males (≥ 50 years of age): 144 samples
  • Females (Premenopausal, 21-49 years of age): 174 samples
  • Females (Postmenopausal, ≥ 50 years of age): 175 samples
  • Total samples: 163 + 144 + 174 + 175 = 656 samples
• Data Provenance: The document states "A new study was conducted in 2014 to calculate FTI or FAI..." It specifies "individuals in the following categories: normal males... normal females..." without explicitly stating the country of origin. The study appears to be prospective in nature, as it was specifically conducted to establish these new expected values.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This is not applicable as the study involves quantitative measurements using an immunoassay device, not subjective expert assessment of images or clinical findings that would require ground truth established by experts.

4. Adjudication Method for the Test Set

• Not applicable for a quantitative in vitro diagnostic assay. The results are raw numerical measurements from the ARCHITECT i System.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not applicable. This is an immunoassay, not an imaging device or an AI/ML algorithm requiring human reader performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable as this is not an AI/ML algorithm. The "standalone" performance here refers to the ARCHITECT SHBG and ARCHITECT 2nd Generation Testosterone assays themselves, which provide quantitative results directly from the instrument.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the quantitative determination of SHBG and Testosterone concentrations in human serum/plasma samples using the respective ARCHITECT assays. These are measured values, not a 'ground truth' in the sense of a consensus diagnosis or pathology result. For FTI/FAI, the ground truth is derived calculation based on these assay results.

8. The Sample Size for the Training Set

• Not applicable as this is not an AI/ML device that undergoes a training phase. The study involved collecting new data to establish expected values for FTI/FAI, effectively acting as a validation/reference range study, not a training set for an algorithm.

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

• Not applicable.

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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.

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.

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