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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 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.

AI/ML Overview

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:

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K Number

K051733

Device Name

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL

Manufacturer

DRG INTL., INC.

Date Cleared

2005-12-07

(162 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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 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.

AI/ML Overview

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