(123 days)
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No
The device description and performance studies describe a standard ELISA kit based on competitive binding and optical density measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) test, specifically an enzyme immunoassay, designed to measure free active testosterone in saliva. IVDs are used for diagnosis and monitoring, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "An Enzyme Immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva." It also details how the measurement of testosterone is used "in the diagnosis and treatment of disorders."
No
The device description clearly outlines a physical ELISA kit with reagents, microplates, and a competition principle based on chemical reactions and optical density measurements. This is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says "An Enzyme Immunoassay for the in vitro diagnostic quantitative measurement of free active testosterone in saliva." It also lists specific diagnostic and treatment applications for the measurement of testosterone.
- Device Description: The description details a laboratory-based test using a microplate and enzyme immunoassay, which is a common format for in vitro diagnostic tests.
- Anatomical Site: The sample is saliva, which is collected from the body but tested outside of it (in vitro).
- Summary of Performance Studies: The document describes various performance studies (Normal Range, Method Comparison, Reproducibility, Recovery, Linearity) that are typical for validating an in vitro diagnostic device.
- Key Metrics: Metrics like Sensitivity, Specificity, Reproducibility, Recovery, and Linearity are all relevant to the performance evaluation of an IVD.
The information provided clearly indicates that this device is intended to be used outside of the body to diagnose or aid in the diagnosis of various medical conditions by measuring a substance in a biological sample (saliva). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CDZ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Saliva
Indicated Patient Age Range
The normal range study included apparently healthy subjects aged 21 to 75 years. The method comparison study included subjects aged 20 to 70 years, and an additional study included subjects aged 40 to 65 years.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device Performance Normal Range Study: Saliva samples from 187 adult male and 188 adult female apparently healthy subjects, ages 21 to 75 years, were collected in the morning and analyzed. Normal range tables are provided for different age groups for both men and women.
Method comparison: A study was performed that evaluated saliva samples from 99 male and female subjects ages 20 to 70 years. The saliva samples were run in duplicate on the DRG test and a commercially available LIA method. A correlation of 0.904 and regression formula of y = 0.9251x - 7.4369 was obtained versus this method. Another study was performed with 81 additional saliva samples collected from 40 - 65 year old men and women. An R2 = 0.9866 was obtained with the regression y = 1.0057x - 2.4196.
Reproducibility (Intra-Assay): Determined by 20 replicate measurements of 5 saliva samples within one run. CV (%) ranges from 6.23 to 13.81.
Reproducibility (Inter-Assay): Determined by duplicate measurements of 5 saliva samples over 10 days. CV (%) ranges from 5.51 to 9.62.
Reproducibility (Inter-Lot): Determined by triplicate measurements of five saliva samples in three different kit lots. CV (%) ranges from 2.90 to 5.85.
Recovery: Determined by adding increasing amounts of analyte to six different saliva samples. Percentage recoveries were determined by comparing expected and measured values. Specific recovery values are listed per sample.
Linearity: Six saliva samples were serially diluted (3 native, 3 spiked) and assayed. The usable range was identified as 7.1 - 4500 pg/mL. Average % Recovery ranges from 97.5 to 100.8, with a range of recovery from 93.6 to 107.8.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: The lowest analytical detectable level of testosterone that can be distinguished from the Zero Standard is 1.857 pg/mL at the 95 % confidence limit. The lowest functional sensitivity of 7.1 pg/mL at the 95% confidence limit was obtained.
Specificity: Evaluation of cross reactivity with various steroids. Testosterone shows 100% cross-reaction. Other steroids show cross-reaction percentages ranging from
§ 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.
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JAN 2 7 2006
SUMMARY OF SAFETY AND EFFECTIVENESS FOR DRG SALIVARY TESTOSTERONE ELISA
| Manufacturer: | DRG International, Inc.
1167 U.S. Highway 22
Mountainside, NJ 07092 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Information: | Lehnus & Associates
Gary Lehnus
150 Cherry Lane Rd.
East Stroudsburg, PA 18301
Tel: (570) 620-0198 |
Device Name / Classification:
The device trade name is the DRG SLV Testosterone ELISA having FDA assigned name: Testosterone test system, 21 CFR, 862.1680, categorized as Class I "reserved" medical devices for the Clinical Chemistry and Clinical Toxicology Panel, as Product Code CDZ.
Test Principle
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.
Device Intended Use:
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.
Device Performance Normal Range Study
In order to determine the normal range of SLV Testosterone, saliva samples from 187 adult male and 188 adult female apparently healthy subjects, ages 21 to 75 years, were collected in the morning and analyzed using the DRG SLV Testosterone ELISA kit. The following range was calculated from this study.
| Men $\male$ | Women $\female$ | |||||
|---|---|---|---|---|---|---|
| Age Group | ||||||
| Years | Range | |||||
| (5 - 95%) | Median | n | Range | |||
| (5 - 95%) | Median | n | ||||
| 21 - 30 | 47.2 - 136.2 | 92.8 | 42 | 7.9 - 50.4 | 20.8 | 40 |
| 31 - 40 | 46.8 - 106.8 | 73.6 | 37 |