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510(k) Data Aggregation
(390 days)
The Pantex Salivary Direct Testosterone EIA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adreno-genital syndromes.
The Pantex Salivary Direct Testosterone EIA kit, Cat # 635 is based on the competition principal and microplate separation. Testosterone calibrators of known concentration, unknown amounts of testosterone in saliva samples and a fixed amount of testosterone (analog) conjugated to horse radish peroxidase (Testosterone-HRP) compete for binding sites with a rabbit monoclonal antiserum bound to GARGG (goat anti-rabbit gamma globulin) coated wells of a microplate. After incubation, unbound components are washed away, enzyme substrate solution is added and a blue color formed. This reaction is stopped with an acid solution to produce a yellow color. The optical density is then read at 450 nm. The amount of Testosterone-HRP detected is inversely proportional to the amount of testosterone in a sample.
The Pantex collection device is a 10 mL, non-sterile, plain polypropylene tube with a screw cap. It is provided as 50 units per package. The expiration date of the Pantex Sample Collection Device is 48 months from the day of manufacture.
The kit consists of a 96 well GARGG (goat anti-rabbit gamma globulin) coated microplate (12x8 breakable strip wells), one concentrated stock testosterone calibrator (62,500 pg/ml), one stock testosterone control (40,000 pg/ml), both traceable to the USP, Anti-Testosterone (rabbit monoclonal), 20X concentrated testosterone-peroxidase (analog), substrate solution, stop reaction solution and 10X concentrated wash solution.
The provided document details the performance characteristics and studies for the Pantex Salivary Direct Testosterone EIA Kit, a medical device for quantitatively measuring testosterone in human saliva. It does not describe an AI/ML powered device, therefore the request for information related to AI/ML is not applicable.
Here's the breakdown of the acceptance criteria and study information provided for this immunoassay kit:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for all performance characteristics in a single table, but lists the results of various validation studies. I will synthesize the stated objectives or implied acceptance targets (e.g., %CV for precision) and the reported performance.
| Performance Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| Intra-assay Precision (%CV) | %CV of ≤10% (implied from "concluded a %CV of ≤10% for each sample tested") | Low: 5.1%, Medium: 2.1%, High: 4.2% |
| Inter-assay Precision (%CV) | %CV of ≤10% (implied) | Low: 6.4%, Medium: 4.6%, High: 3.1% |
| Inter-lot Precision (%CV) | %CV of ≤10% (stated) | Sample 1: 1.5%, Sample 2: 2.2%, Sample 3: 7.2%, Sample 4: 6.2%, Sample 5: 6.0%, C1: 4.0%, C2: 4.2% |
| Repeatability (%CV) | Not explicitly stated, values presented | Low: 3.8%, Medium: 2.5%, High: 2.5%, Control 1: 4.6%, Control 2: 1.8% |
| Linearity | Linearity over the assay measuring range | Linear from 5.5 - 650.0 pg/mL (Y=0.9597x + 3.335, R2 = 0.99685) |
| Recovery | Acceptable percentage recovery of spiked samples | Range: 92.4% - 108.9% |
| Manual Dilution | Acceptable percentage recovery for diluted samples | Range: 96.0% - 109.5% |
| Reagent Stability | Defined stability period and storage conditions | 4 months at 2-8°C (long-term study ongoing) |
| Open Vial Stability | Defined stability period | 31 days at 2-8°C |
| Working Testosterone-HRP Conjugate | Defined stability period | 31 days at 2-8°C |
| Diluted working calibrator/control | Defined stability period | 31 days at 2-8°C |
| Sample Stability | Defined stability periods under various conditions | 20-28°C: Up to 7 days, 37°C: Up to 7 days, 2-8°C: Up to 7 days, ≤-15°C (7 freeze/thaw cycles): Up to 7 days, ≤-15°C (Long term): Up to 180 days |
| In-transit Stability | Defined stability period | Up to 9 days |
| After Returning Stability | Defined stability periods | 20-28°C: Up to 7 days, 37°C: Up to 7 days, 2-8°C: Up to 7 days, ≤-15°C: Up to 7 days |
| Detection Limits | Defined LoB, LoD, LoQ values | LoB: 1.8 pg/mL, LoD: 2.1 pg/mL, LoQ: 3.9 pg/mL |
| Method Comparison | Strong correlation ($R^2$) with predicate device | $Y = 0.9035X + 5.81$, $R^2 = 0.98$ |
| Interference Studies | No significant interference from common consumables | No significant interference from coffee, food, gum, alcohol, cigarette smoke. Interference seen with whole blood, sodium azide, and thimerosal |
2. Sample sizes used for the test set and the data provenance
- Precision/Reproducibility:
- Intra-assay: 20 replicates of 3 saliva pools (low, medium, high).
- Inter-assay: Average of duplicates for 12 separate assays of 3 saliva pools.
- Inter-lot: Duplicate measurements of 5 saliva samples and 2 spiked controls, using 3 different reagent lots.
- Repeatability: 100 measurements for each of 3 saliva pools and 2 controls over 20 days (2 assays/day, minimum 1 hour between assays).
- Linearity: 10 sample concentrations (dilutions).
- Recovery: 7 saliva samples containing different endogenous testosterone levels, spiked with known quantities.
- Manual Dilution: 6 samples (3 endogenous, 3 spiked).
- Expected Reference Values: 120 male saliva samples and 120 female saliva samples (total 240 samples for establishing reference ranges).
- Detection Limits: Several low testosterone samples, assayed twice per day over 3 days using 2 different reagent lot numbers.
- Method Comparison: 106 samples (range 6.45-458.35 pg/ml), including 9 spiked samples (8.5% of total, range 252.1 - 424.2 pg/mL).
- Interference Studies (in-vivo simulated experiment): Saliva samples from subjects (number not specified, but at least 4 shown in the table: JGA/JGB, MGA/MGB, DGA/DGB, RGA/RGB) before and after contact with 5 common products (coffee, food, gum, alcohol, cigarette smoke).
- Interference Studies (potential interferents): Three potential interferents (whole blood, sodium azide, thimerosal) tested at four concentrations (0.05%, 0.10%, 0.25% and 0.5%) on salivary testosterone samples (number of samples not specified).
Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective in nature, as they involve actively conducting experiments (e.g., preparation of samples, running assays, collecting samples before/after interventions).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device is an immunoassay kit, not an AI/ML-powered diagnostic device that would typically rely on expert-established ground truth for its performance assessment in the manner described (e.g., radiologist interpreting images). The "ground truth" for this device's performance is established through quantitative measurements of testosterone in clinical samples and reference materials, using established analytical methods and traceable standards. Therefore, the concept of "number of experts" and "qualifications of those experts" for ground truth establishment in this context is not directly applicable in the same way it would be for AI/ML image analysis. The performance is assessed against known concentrations, reference intervals, and comparison to a legally marketed predicate device.
4. Adjudication method for the test set
Not applicable. This is an immunoassay-based diagnostic device where results are quantitative measurements, not subjective interpretations requiring adjudication.
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 immunoassay kit for quantitative measurement and does not involve human readers or AI assistance in the way described for an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is an immunoassay kit and not an algorithm. Its performance is tested as a standalone diagnostic tool.
7. The type of ground truth used
The ground truth for this device's performance relies on:
- Known Concentrations: For precision, linearity, recovery, and dilution studies, samples are either prepared with known concentrations of testosterone or spiked with known quantities. The synthetic Testosterone used is traceable to the U.S. Pharmacopeia (USP) catalog number 1646009, Lot number J0G360.
- Comparison to Predicate Device: For method comparison, the device's results are compared against those from a legally marketed predicate device (IBL Testosterone LIA, K033786).
- Reference Intervals: For expected values, reference ranges are established by testing a large population of male and female subjects (120 of each).
- Statistical Analysis: Performance is evaluated using statistical measures like %CV, R-squared values, and recovery percentages, aligned with CLSI guidelines.
8. The sample size for the training set
Not applicable. This is an immunoassay kit; it does not involve a "training set" in the context of machine learning. The various studies (precision, linearity, recovery, etc.) validate the analytical performance of the kit itself.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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