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510(k) Data Aggregation
(518 days)
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(123 days)
An Enzyme Immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delaved or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
The DRG Salivary Testosterone ELISA Kit is based on the competition princible and the microplate separation. An unknown amount of free testosterone present in the sample and a fixed amount of testosterone conjugated with horseradish peroxidase compete for the binding sites of mouse monoclonal testosterone -antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the substrate solution the concentration of testosterone is inversely proportional to the optical density measured.
The DRG Salivary Testosterone ELISA is a diagnostic device used for the quantitative measurement of free-active testosterone in saliva. The device performance was evaluated through various studies, including method comparison, sensitivity, specificity, reproducibility, recovery, and linearity.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Normal Range | Establish a 5-95% reference range for apparently healthy adult males and females across different age groups. | Determined from 187 adult males (21-75 years) and 188 adult females (21-75 years). Males (pg/mL):- 21-30: 47.2 - 136.2- 31-40: 46.8 - 106.8- 41-50: 36.5 - 82.7- 51-60: 19.1 - 89.0- 61-75: 12.2 - 68.6 Females (pg/mL):- 21-30: 7.9 - 50.4- 31-40: <7.0 - 44.8- 41-50: <7.0 - 39.4- 51-60: <7.0 - 29.8- 61-75: <7.0 - 29.3 |
| Method Comparison | Demonstrate substantial equivalence to a commercially available LIA method for measuring testosterone in saliva, typically indicated by a strong correlation coefficient and acceptable regression analysis. Consistency in reporting is implicitly expected though specific thresholds are not provided. | Study 1: 99 male and female subjects (20-70 years). - Correlation: 0.904 - Regression: y = 0.9251x - 7.4369 (vs LIA)Study 2: 81 additional saliva samples (40-65 year old men and women). - R² = 0.9866- Regression: y = 1.0057x - 2.4196 (DRG ELISA vs LIA) |
| Sensitivity | The lowest detectable level of testosterone distinguishable from a zero standard (analytical sensitivity) and the lowest functional sensitivity at a specified confidence limit. | - Lowest analytical detectable level: 1.857 pg/mL at 95% confidence limit.- Lowest functional sensitivity: 7.1 pg/mL at 95% confidence limit. |
| Specificity | Minimal cross-reactivity with other related steroids and compounds, particularly those structurally similar, to ensure accurate testosterone measurement. | - Testosterone: 100%- 5α-Dihydrotestosterone: 0.80%- Androstenedione: 0.90%- 11β-hydroxysterone: 3.30%- 17α-methyltestosterone: 0.10%- 19-Nortestosterone: 3.30%- Epitestosterone: 0.10%- Estradiol: 0.10%- Progesterone: < 0.10%- Cortisol: < 0.10% - Estrone: < 0.10%- Danazol: < 0.10% |
| Reproducibility | Demonstrate acceptable variability (CV%) for intra-assay (within-run), inter-assay (between-run), and inter-lot (between-kit-lots) measurements across a range of testosterone concentrations. Typically, CV% values should be low, indicating precision. | Intra-Assay (n=20 replicates/sample per run):- CV% range: 6.23% - 13.81% (across 5 samples with mean range 12.94-144.00 pg/mL)Inter-Assay (n=20 duplicate measurements over 10 days/sample):- CV% range: 5.51% - 9.62% (across 5 samples with mean range 33.61-823.08 pg/mL)Inter-Lot (n=9 triplicate measurements over 3 kit lots/sample):- CV% range: 2.90% - 5.85% (across 5 samples with mean range 44.00-517.65 pg/mL) |
| Recovery | Recover close to 100% of added analyte in spiked samples, demonstrating accuracy and lack of matrix interference. A typical range for acceptable recovery is 90-110%. | Average Recovery: - Range from 92.35% to 104.92% (from 6 saliva samples with various spiked concentrations).Individual Recoveries (selected examples from samples 1-6):- 95.56%, 101.73%, 104.92%, 95.82%- 97.19%, 103.32%, 104.30%, 92.35%- 99.25%, 95.03%, 94.75%, 96.69%- 97.8%, 98.6%, 100.0%- 98.7%, 96.0%, 97.7%- 99.1%, 102.3%, 100.5% |
| Linearity | Demonstrate that the assay provides proportional results across its claimed analytical measurement range, typically assessed by percentage recovery of serially diluted samples. An acceptable range for recovery is generally 90-110%. The functional range should be clearly defined. | Usable Range: 7.1 - 4500 pg/mL.Average % Recovery: 97.5% - 100.8% (for 6 samples with concentrations from 440.00 to 8000.0 pg/mL).Range of Recovery %: - From 93.6% to 107.8% (across 6 samples). (Three native samples were serially diluted, and 3 samples were spiked and then serially diluted up to 1:128). |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Normal Range Study: 187 adult male and 188 adult female apparently healthy subjects (ages 21-75 years). Samples were collected in the morning. Data provenance is not explicitly stated beyond "apparently healthy subjects," but given the domestic contact information (New Jersey) and FDA submission, it implicitly refers to data collected within the US or compliant with US regulatory standards. This appears to be a prospective collection for this study.
- Method Comparison (Study 1): 99 male and female subjects (ages 20-70 years).
- Method Comparison (Study 2): 81 additional saliva samples from 40-65 year old men and women.
- Sensitivity: Not specified as a separate test set, derived from standard curve analysis.
- Specificity: Not specified as a separate test set, derived from testing specific steroids and compounds.
- Reproducibility (Intra-assay): 5 saliva samples, 20 replicate measurements per sample.
- Reproducibility (Inter-assay): 5 saliva samples, duplicate measurements over 10 days per sample.
- Reproducibility (Inter-lot): 5 saliva samples, triplicate measurements in three different kit lots per sample.
- Recovery: 6 different saliva samples.
- Linearity: 6 saliva samples (3 native, 3 spiked).
The data provenance for all studies is not explicitly stated but is implicitly within the context of a US-based manufacturer seeking FDA clearance, suggesting data generated for this purpose. The studies described are likely prospective or specifically conducted for the validation of this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This device is an immunoassay for quantitative measurement. The "ground truth" for such devices often refers to the actual concentration of the analyte, established either by:
* Traceability to recognized reference materials/methods.
* Performance against a well-established, validated comparative method (often called a "predicate" device in regulatory submissions, or a "gold standard" method).
In this context, the "ground truth" for the method comparison studies was established by a "commercially available LIA method" (presumably the predicate device or a reference method). No human experts or their qualifications are mentioned for establishing the ground truth for this type of quantitative assay, as the measurement is chemical/analytical.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative assessments, especially in imaging or clinical diagnosis where human interpretation is involved. For a quantitative immunoassay like this, the result is a numerical value, and "adjudication" in the traditional sense is not performed. Accuracy is determined by comparing measured values to known concentrations or reference method results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices or other tools where human interpretation of results is a critical component and the effect of AI on human reader performance is being evaluated. This device is an automated, quantitative immunoassay.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone study was done. All performance metrics described (Method Comparison, Sensitivity, Specificity, Reproducibility, Recovery, Linearity) represent the performance of the DRG SLV Testosterone ELISA device itself, in an automated or semi-automated laboratory setting, without direct human-in-the-loop interpretation impacting the measurement results.
7. The Type of Ground Truth Used:
The primary ground truth used for performance evaluation was:
- Comparative Method: For method comparison studies, the results from a "commercially available LIA method" were used as the reference to assess the DRG device's agreement and substantial equivalence.
- Spiked Samples/Known Concentrations: For sensitivity, recovery, and linearity studies, known concentrations of testosterone (either added to samples or derived from serial dilutions) served as the ground truth.
- Reference Materials: Implicitly, the sensitivity and specificity characterization would rely on well-characterized reference materials or pure chemical compounds.
8. The Sample Size for the Training Set:
This document describes a diagnostic assay kit (ELISA), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are validation studies to characterize the assay's analytical performance.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for an ELISA kit. The "ground truth" (i.e., reference values) for the validation studies were established as described in section 7.
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(162 days)
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free cortisol (hydrocortisone and hydroxycorticosterone) in saliva. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
The DRG Salivary Cortisol ELISA KIT is based on the competition principle and the microplate separation. An unknown amount of Cortisol present in the sample and a fixed amount of Cortisol coniugated with horseradish peroxidase compete for the binding sites of mouse polyclonal Cortisol-antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the TMB substrate solution the concentration of Cortisol is inversely proportional to the optical density measured.
Here's an analysis of the provided text regarding the DRG Salivary Cortisol ELISA, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the performance data presented, as explicit criteria (e.g., "must achieve X correlation") are not stated. The performance is reported against other commercially available methods or standard analytical techniques.
| Performance Metric | Implied Acceptance Criteria (Based on context) | Reported Device Performance |
|---|---|---|
| Method Comparison (vs. LIA) | High correlation (e.g., >0.85) | 0.872 (Study 1, n=114) |
| High correlation (e.g., >0.95) for expanded study | 0.9795 (Expanded Study 1, n=40) | |
| Method Comparison (vs. EIA) | High correlation (e.g., >0.90) | 0.936 (Study 2, n=72) |
| High correlation (e.g., >0.95) for expanded study | 0.9920 (Expanded Study 2, n=40) | |
| Method Comparison (vs. LC-MS) | High correlation (e.g., >0.85) | 0.89056 (Study 3, n=28) |
| Sensitivity (Lowest Detectable Limit) | As low as reasonably achievable for clinical utility (no specific numerical criterion given) | 0.537 ng/mL or 0.0537 ug/dl at 95% confidence limit |
| Specificity (Cross-Reactivity) | Low cross-reactivity with structurally similar compounds | Cortisol: 100%, Corticosterone: 29.00%, Cortisone: 3.00%, most others <1% or <0.5% |
| Intra-Assay Reproducibility (CV) | Low CV (typically <10-15%) | Data missing for this section in the provided text. |
| Inter-Assay Reproducibility (CV) | Low CV (typically <15-20%) | 7.47% (24.29 ng/mL mean), 5.82% (40.85 ng/mL mean) |
| Inter-Lot Reproducibility (CV) | Low CV (typically <15-20%) | Data missing for this section in the provided text. |
| Recovery | % Recovery within a generally accepted range (e.g., 80-120%) | Range of 90.1% to 108.8% across various spiked samples and concentrations. |
| Linearity (% Recovery) | % Recovery within a generally accepted range (e.g., 80-120%) | Average % Recovery: Sample 1: 107.0%, Sample 2: 99.1%, Sample 3: 97.5%. Range of % Recovery: Sample 1: 101.1-114.0%, Sample 2: 97.8-99.6%, Sample 3: 92.4-104.4% |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the samples used for method comparison and performance evaluation.
- Normal Range Study: 109 saliva samples. Adult male and female apparently healthy subjects, ages 20 to 80 years. Morning collection. (Provenance not specified, but likely domestic to DRG International, Inc. in NJ, USA, or related clinical sites). Prospective in nature.
- Method Comparison (Study 1 vs. LIA): 114 saliva samples. Subjects ages 40 to 70 years. (Provenance not specified). Retrospective implied as samples were "run".
- Method Comparison (Study 2 vs. EIA): 72 saliva samples. Men ages 40 to 70 years. (Provenance not specified). Retrospective implied.
- Method Comparison (Study 3 vs. LC-MS): 28 saliva samples. (Provenance not specified). Retrospective implied.
- Expanded Method Comparison (Study 1 vs. LIA): 40 saliva samples. Subjects ages 25-65 years. (Provenance not specified). Retrospective implied.
- Expanded Method Comparison (Study 2 vs. EIA): 40 saliva samples. Men and women ages 25-65 years. (Provenance not specified). Retrospective implied.
- Sensitivity: This is typically an in-vitro measurement using dilutions of known concentrations, not patient samples.
- Specificity: In-vitro evaluation of various steroid compounds.
- Reproducibility (Intra- and Inter-Assay): 4 saliva samples for intra-assay; commercial control samples for inter-assay.
- Reproducibility (Inter-Lot): 5 saliva samples.
- Recovery: 3 saliva samples with endogenous cortisol spiked with known amounts.
- Linearity: 3 saliva samples serially diluted.
The provenance regarding country of origin is not explicitly stated for any of the patient samples, but given the manufacturer's location, US-based samples are a reasonable assumption for a US regulatory submission. All studies appear to be retrospective analyses of collected samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of diagnostic device (ELISA kit for cortisol) doesn't typically rely on human expert interpretation of images or complex data for "ground truth" in the way an AI imaging device would. Instead, the ground truth for method comparison studies is established by:
- Reference method: Commercial LIA, EIA, and LC-MS methods. These methods are themselves established, and their results are treated as the "ground truth" for comparison.
- Known concentrations: For sensitivity, specificity, recovery, and linearity studies, known concentrations of cortisol or interfering substances are used.
Therefore, the concept of "experts establishing ground truth for the test set" is not directly applicable in the same way as for subjective diagnostic tasks. The performance is compared against existing, validated analytical methods.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the "ground truth" for this type of device is established through comparison with recognized analytical methods or known sample concentrations, not through expert adjudication of subjective findings.
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 is an ELISA kit, a laboratory diagnostic test measuring a biochemical marker. It does not involve human "readers" or "AI assistance" in the interpretation of complex data (like medical images) where MRMC studies are relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This is an in vitro diagnostic (IVD) kit. Its performance is inherently standalone, in that it provides a quantitative result based on the chemical reaction. There's no "human-in-the-loop" component in the interpretation of the raw assay signal (optical density) to derive the cortisol concentration once the assay is run and the standard curve is established. The device itself is the "algorithm only" (chemical reaction and measurement) to produce the result.
7. The Type of Ground Truth Used
The ground truth for the performance studies was primarily established by:
- Reference analytical methods: Commercially available LIA (Luminescence Immunoassay) and EIA (Enzyme Immunoassay) methods, and a reference LC-MS (Liquid Chromatography-Mass Spectrometry) method.
- Known concentrations: For sensitivity, specificity (known cross-reactants), recovery (spiked samples with known added cortisol), and linearity (serum samples with known dilutions).
8. The Sample Size for the Training Set
This document describes a premarket notification (510(k)) for a traditional IVD device. The language "training set" is typically associated with machine learning or AI algorithm development. For an ELISA kit, there isn't a "training set" in that sense. The kit's reagents, protocols, and standard curve parameters are developed through R&D experiments and optimization processes, but this is not typically referred to as a "training set" for an algorithm. The reported studies (method comparison, reproducibility, etc.) are essentially validation studies for the finalized product.
9. How the Ground Truth for the Training Set Was Established
As there isn't a "training set" for an algorithm in the AI sense, this question is not directly applicable. The "ground truth" for the development and optimization of the ELISA kit would involve established biochemical principles and highly controlled experiments using known concentrations of cortisol and other substances, likely following established laboratory practices for assay development.
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(102 days)
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