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The IBL International Cortisol Saliva Luminescence Immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.

Device Description

Cortisol (also known as hydrocortisone, compound F) is the main glucocorticoid in humans and is produced in the zona fasciculata of the adrenal cortex. 90 % of the circulating cortisol are bound to corticoid binding globulin (CBG, Transcortin), ca. 7 % are bound to albumin and only 1-3 % are unbound. Only the latter part represents the active form of cortisol. The free cortisol is released in saliva and is excreted via the kidneys as a small part among the metabolites of cortisol. The level of free cortisol in blood regulates mainly its secretion in the adrenal cortex in a negative feedback mechanism via CRH (corticotropin releasing hormone) in the hypothalamic region and the ACTH in the pituitary gland, but it is also affected by different situations above all by stress.

In humans, there is a physiological fluctuation of cortisol achieving the highest level in the morning and the lowest during the night. This fluctuation of cortisol plasma level is reflected in saliva normally with a peak in the first 90 minutes after waking up. The cortisol measurement is indicated in adrenal disorders. Due to the diurnal fluctuations of cortisol, a salivary sample collection is an easy method without the stress of repeated venipunctures.

Test principle:
Luminescence immunoassay based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.

Device composition:
The device is available in two sizes, 96 tests and 960 tests.

The device consists of an antibody coated 96 well Microtiter Plate, seven Standards (range 0.015 - 3.20 µg/dL, equivalent to 0.15 - 32 ng/mL calibrated to the NIST cortisol), two Controls, Enzyme Conjugate (Cortisol coupled to peroxidase), Chemiluminescence Reagent 1 and 2, 10x concentrated Wash Buffer, Adhesive Foils.

AI/ML Overview

The provided document describes the IBL International Cortisol Saliva Luminescence Immunoassay, a device for in-vitro diagnostic quantitative determination of Cortisol in human saliva, intended as an aid in diagnosing and treating adrenal disorders. The device's performance was evaluated through various analytical studies and a method comparison with a predicate device.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" separate from the "reported device performance." Instead, it describes various performance characteristics and their outcomes, implying that the achieved outcomes met the internal acceptance criteria for substantial equivalence. I will synthesize the reported performance characteristics that implicitly serve as acceptance criteria.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Detection Limits	Sufficiently low	LoB: 0.004 µg/dL
		LoD/LoQ study performed.
Specificity (Cross-reactivity)	Interfering substances at high concentrations should not significantly impact results.	Prednisolone: ≥10% cross-reactivity at 10,000 µg/dL. 11-Deoxycortisol: ≥5% cross-reactivity at 10,000 µg/dL.
Linearity	Strong linear correlation.	Determined Cortisol concentration (µg/dL) = -0.05 + 1.03 x (expected Cortisol concentration (ug/dL)), with R² = 0.99. Linear range: 0.012 µg/dL (LoQ) to 3.134 µg/dL.
Recovery	Acceptable range of recovery.	93.7% – 109.6% for tested samples with expected concentrations 0.242 µg/dL to 2.528 µg/dL.
Precision	Low variability (CV).	Between-lot CV range: 0.4 – 1.7%. Between-operator CV range: 0.8 – 1.8%.
Sample Freezing Claim (CV)	CV after freezing should be lower than without freezing.	Mean CV = 4.4% after freezing vs. 7.2% without freezing.
Sample Stability	Cortisol concentration within predetermined acceptance range across tested conditions.	Storage Conditions & Stability:

37°C: 1 week
18-25°C: 2 weeks
2-8°C: 2 weeks

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