(256 days)
The IDS Cortisol assay is an in vitro diagnostic device intended for the quantitative determination of cortisol in human serum and plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.
The IDS Cortisol assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:
- MPE1:Magnetic particles coated rat anti-mouse monoclonal antibody in a phosphate buffer with Proclin as preservative.
- CONJ: Cortisol coupled with an acridinium ester derivative in = phosphate buffer with Proclin as a preservative.
- mAb: Mouse anti-cortisol monoclonal antibody in phosphate buffer with Proclin as a preservative .;
- BUF: HEPES buffer containing Proclin as preservative .
This document describes the analytical performance of the IDS Cortisol assay, an in vitro diagnostic device, and demonstrates its substantial equivalence to a predicate device (Roche Elecsys Cortisol II). The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this in vitro diagnostic device are primarily based on demonstrating analytical performance that is comparable to, or meets specified standards relative to, established laboratory methods and a predicate device.
| Performance Characteristic | Acceptance Criteria (from context/implied standard) | Reported Device Performance (IDS Cortisol) |
|---|---|---|
| Precision | Repeatability (Within-run): Lower CV% | Within-Run / Repeatability (n=80 per sample, 1 lot, 1 system): |
- 0.94 µg/dL: 7.8% CV
- 1.84 µg/dL: 4.6% CV
- 5.75 µg/dL: 2.4% CV
- 13.06 µg/dL: 2.4% CV
- 19.94 µg/dL: 1.8% CV
- 44.63 µg/dL: 1.9% CV
|
| | Intermediate Precision (Within-System/Total): Lower CV% | Within-System (n=80 per sample, 1 lot, 1 system): - 0.94 µg/dL: 16.2% CV
- 1.84 µg/dL: 10.9% CV
- 5.75 µg/dL: 5.2% CV
- 13.06 µg/dL: 3.9% CV
- 19.94 µg/dL: 5.1% CV
- 44.63 µg/dL: 4.2% CV
Total (Combind 3 lots, 3 systems, n=240 per sample): - 0.88 µg/dL: 15.3% CV
- 1.78 µg/dL: 10.1% CV
- 5.75 µg/dL: 4.5% CV
- 13.09 µg/dL: 3.3% CV
- 20.22 µg/dL: 4.8% CV
- 44.48 µg/dL: 5.0% CV |
| Linearity/Reportable Range | Data should demonstrate linearity across the claimed measuring range. | Measuring Range: 0.59 to 45.00 µg/dL.
Regression: Observed = 1.01 * Expected + 0.01 µg/dL; R²: 1.00
(Accepted based on R² close to 1 and slope ~1, intercept ~0) |
| Detection Limits (LoB, LoD, LoQ) | Specific quantifiable low limits. | LoB: 0.10 µg/dL
LoD: 0.24 µg/dL
LoQ: 0.59 µg/dL |
| Analytical Specificity (Interference) | Non-significant bias (
§ 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.