(587 days)
For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.
The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.
Here's a breakdown of the acceptance criteria and study information for the Pantex AM/PM Salivary Cortisol EIA Kit, based on the provided text:
The provided text focuses on the analytical performance of the Pantex AM/PM Salivary Cortisol EIA Kit and its equivalence to a predicate device. It demonstrates the device's ability to accurately and reliably measure salivary cortisol levels.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied / Contextual) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | %CV ≤ 10% (for intra-assay, inter-assay, inter-lot) | Intra-assay: Low (5.4%), Medium (6.7%), High (6.3%) %CV |
| Inter-assay: Low (6.3%), Medium (7.2%), High (2.8%) %CV | ||
| Inter-lot: %CV range of 0.9% to 7.4% for various samples and controls. | ||
| Linearity | Desired Recovery % (Typically 90-110%) | Recovery ranging from 93.0% to 101.4% across 10 concentrations |
| Recovery | Desired Recovery % (Typically 90-110%) | Recovery ranging from 93.7% to 103.9% across 10 spiked samples |
| Reagent Stability | Demonstrated shelf life | 9 months when stored at 2-8°C |
| Sample Stability | Demonstrated stability under various conditions | Room Temperature (20-30°C): Up to 7 days |
| 37°C: Up to 7 days | ||
| 2-8°C: Up to 7 days |
§ 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.