(162 days)
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No
The device description and performance studies detail a standard enzyme immunoassay (ELISA) kit, which relies on chemical reactions and optical density measurements, not AI/ML algorithms for analysis or interpretation. There are no mentions of AI, ML, or related concepts in the summary.
No.
This device is an immunoassay kit used for quantitative in vitro diagnostic measurement of active free cortisol in saliva, which helps in the diagnosis and treatment of adrenal gland disorders. It is a diagnostic tool, not a therapeutic one that directly treats or prevents disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "quantitative in vitro diagnostic measurement" and that "Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland." This directly indicates its purpose as a diagnostic device.
No
The device is described as an "enzyme immunoassay kit" and details the chemical and biological components and processes involved in the test, indicating it is a hardware-based diagnostic kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement clearly indicates that the device is intended for use in vitro (outside of the body) for diagnostic purposes, specifically for measuring cortisol in saliva to aid in the diagnosis and treatment of adrenal gland disorders. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NHG
Device Description
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.
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
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Indicated Patient Age Range
Adults: 20 to 80 years for normal range study. 40 to 70 years for method comparison study 1. 40 to 70 years for method comparison study 2. 25 - 65 years for expanded comparison study 1. 25 - 65 years for expanded comparison study 2.
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
Normal Range Study: 109 saliva samples from adult male and female apparently healthy subjects, ages 20 to 80 years, were collected in the morning.
Method comparison (Study 1): 114 saliva samples from subjects ages 40 to 70 years.
Method comparison (Study 2): 72 saliva samples collected from 40 - 70 year old men.
Method comparison (Study 3): 28 saliva samples.
Expanded comparison (Study 1): 40 saliva samples from subjects ages 25 - 65 years.
Expanded comparison (Study 2): 40 saliva samples collected from men and women ages 25 - 65 years.
Intra-Assay Reproducibility: 4 saliva samples.
Inter-Assay Reproducibility: Commercial control samples (n=12 for each of two concentrations).
Inter-Lot Reproducibility: 5 saliva samples.
Recovery: Three different saliva samples.
Linearity: Three saliva samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Normal Range Study:
- Study Type: Determination of normal range.
- Sample Size: 109 saliva samples.
- Key Results: Normal range determined as 0.12 - 1.47 µg/dL or 1.2 - 14.7 ng/mL (AM collection) for Adults.
Method Comparison Studies:
- Study 1: Compared DRG SLV Cortisol test to another commercially available LIA method.
- Sample Size: 114 subjects.
- Key Results: A correlation of 0.872 was obtained.
- Study 2: Compared DRG SLV Cortisol test to another commercially available EIA test.
- Sample Size: 72 saliva samples.
- Key Results: A correlation of 0.936 was observed.
- Study 3: Compared DRG SLV Cortisol test to a reference LC-MS method.
- Sample Size: 28 saliva samples.
- Key Results: A correlation of r = 0.89056 with a formula of y = 1.0144x + 1.7762 was obtained.
Expanded Comparison Studies:
- Study 1: Compared DRG SLV Cortisol test to another commercially available LIA method.
- Sample Size: 40 subjects.
- Key Results: An overall correlation of 0.9795 and a regression formula of y = 0.9588x - 0.0338 was obtained.
- Study 2: Compared DRG SLV Cortisol test to another commercially available EIA test.
- Sample Size: 40 saliva samples.
- Key Results: A correlation of 0.9920 with a regression formula of y = 1.0722x + 0.1482 was observed.
- Key Results Summary: The DRG Cortisol ELISA test demonstrated equivalent performance to commercially available ELISA and LIA methods for detection of Cortisol in saliva.
Sensitivity:
- Key Results: The lowest detectable level of Cortisol that can be distinguished from the Zero Standard is 0.537 ng/mL or 0.0537 ug/dl at the 95 % confidence limit.
Specificity:
- Key Results: Cross-reactivity percentages for various steroids were evaluated (e.g., Cortisol 100%, Corticosterone 29.00%, Cortisone 3.00%).
Reproducibility:
- Intra-Assay: Determined by replicate measurements of 4 saliva samples.
- Inter-Assay: Determined by quadruplicate measurements of commercial control samples in three different days runs. CV (%) for 24.29 ng/mL was 7.47, and for 40.85 ng/mL was 5.82.
- Inter-Lot: Determined by duplicate measurements of five saliva samples in three different kit lots.
Recovery:
- Key Results: Percentage recoveries for spiked samples ranged from 90.1% to 108.8%.
Linearity:
- Key Results: An assay linearity of 0.537 - 77 ng/mL has been identified as the usable range. Average % Recovery ranged from 97.5% to 107.0% across three samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.537 ng/mL or 0.0537 ug/dl at the 95% confidence limit.
Specificity: Cross-reactivity: Cortisol 100%, Corticosterone 29.00%, Cortisone 3.00%, 11-Deoxycortisol
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.
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DEC 7 2005
SUMMARY OF SAFETY AND EFFECTIVENESS FOR DRG SALIVARY CORTISOL 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 Cortisol ELISA having FDA assigned name: Cortisol test system, 21 CFR, 862.1205, categorized as Class II medical devices for the Clinical Chemistry and Clinical Toxicology Panel, as Product Code NHG.
Test Principle
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.
Device Intended Use:
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.
Device Performance
Normal Range Study
In order to determine the normal range of SLV cortisol, 109 saliva samples from adult male and female apparently healthy subjects, ages 20 to 80 years, were collected in the morning and analyzed using the DRG SLV Cortisol ELISA kit. The following range was calculated from this study.
0.12 - 1.47 µg/dL or 1.2 - 14.7 ng/mL (AM collection) Adults:
Method comparison
Studies were performed to compare the DRG SLV Cortisol test to commercially available tests. One study evaluated saliva samples from 114 subjects ages 40 to 70 years. The samples were run in duplicate on the DRG test and another commercially available LIA method to determine the concentration of Cortisol in the samples. A correlation of 0.872 was obtained versus this method.
A second study was performed using saliva samples from seventy-two (72) saliva samples collected from 40 - 70 year old men and run in duplicate on DRG
1
and another commercially available EIA test. A correlation of 0.936 was observed compared to another EIA method.
Another study was performed comparing 28 saliva samples to a reference LC-MS method. A correlation of r = 0.89056 with a formula of y = 1.0144x + 1.7762 was obtained to this method.
To further demonstrate substantial equivalence of the DRG SLV test, additional expanded comparison studies were requested. One expanded study evaluated saliva samples from 40 subjects ages 25 - 65 years. The samples were run in duplicate on the DRG test and another commercially available LIA method to determine the concentration of Cortisol in the samples. An overall correlation of 0.9795 and a regression formula of y = 0.9588x - 0.0338 was obtained versus this method.
A second expanded study was performed using 40 saliva samples collected from men and women ages 25 - 65 years and run in duplicate on DRG and another commercially available EJA test. A correlation of 0.9920 with a regression formula of y = 1.0722x + 0.1482 was observed compared to another EIA method.
The DRG Cortisol ELISA test demonstrated equivalent performance to commercially available ELISA and LIA methods for detection of Cortisol in saliva.
Sensitivity
The lowest detectable level of Cortisol that can be distinguished from the Zero Standard is 0.537 ng/mL or 0.0537 ug/dl at the 95 % confidence limit.
Specificity
The following materials have been evaluated for cross reactivity. The percentage indicates cross reactivity at 50% displacement compared to Cortisol.
| Steroid | % Cross
reaction |
|-----------------------------------|---------------------|
| Cortisol | 100% |
| Corticosterone | 29.00% |
| Cortisone | 3.00% |
| 11-Deoxycortisol |