(190 days)
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.
| Acceptance Criteria (Implicit for FTI/FAI Study) | Reported Performance (FTI/FAI Expected Values) |
|---|---|
| New FTI/FAI expected values are derived from a sufficient number of representative samples across different demographic categories. | See tables below for the calculated median, 2.5th, and 97.5th percentiles for SHBG, Testosterone, and %FTI/%FAI for various demographic groups. |
| The individual SHBG and Testosterone measurements used to calculate FTI/FAI fall within the expected values of their respective ARCHITECT assays. | Samples were included if they were within the expected values of the ARCHITECT 2nd Generation Testosterone (LN 2P13) and ARCHITECT SHBG (LN 8K26) reagent inserts. |
| The labeling update does not alter the intended use, indications for use, or fundamental scientific technology of the predicate device. | Confirmed in the conclusion. RLI analysis performed, no change in performance expected. |
SHBG Expected Values (nmol/L)
| Category | N | Median | 2.5th Percentile | 97.5th Percentile |
|---|---|---|---|---|
| Males (21-49 years of age) | 163 | 31.1 | 16.2 | 68.5 |
| Males (≥ 50 years of age) | 144 | 35.3 | 13.7 | 69.9 |
| Females (Premenopausal, 21-49 years of age) | 174 | 48.6 | 14.7 | 122.5 |
| Females (Postmenopausal, ≥ 50 years of age) | 175 | 49.9 | 16.7 | 124.4 |
Testosterone Expected Values
| Category | N | Median (nmol/L [ng/dL]) | 2.5th Percentile (nmol/L [ng/dL]) | 97.5th Percentile (nmol/L [ng/dL]) |
|---|---|---|---|---|
| Males (21-49 years of age) | 163 | 15.33 [442.07] | 8.76 [252.73] | 27.85 [803.24] |
| Males (≥ 50 years of age) | 144 | 14.42 [415.85] | 8.58 [247.50] | 23.37 [674.13] |
| Females (Premenopausal, 21-49 years of age) | 174 | 1.05 [30.43] | 0.52 [14.92] | 1.72 [49.56] |
| Females (Postmenopausal, ≥ 50 years of age) | 175 | 0.76 [21.83] | 0.46 [13.34] | 1.18 [33.90] |
% FTI or % FAI Expected Values
| Category | N | Median (%) | 2.5th Percentile (%) | 97.5th Percentile (%) |
|---|---|---|---|---|
| Males (21-49 years of age) | 163 | 46.6 | 24.5 | 113.3 |
| Males (≥ 50 years of age) | 144 | 40.7 | 19.3 | 118.4 |
| Females (Premenopausal, 21-49 years of age) | 174 | 2.0 | 0.7 | 8.7 |
| Females (Postmenopausal, ≥ 50 years of age) | 175 | 1.5 | 0.5 | 4.7 |
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.
§ 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.