(264 days)
Immunoassay for the in vitro quantitative determination of cortisol in human serum, and plasma. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Cortisol II CalSet is used for calibrating the quantitative Elecsys Cortisol II assay on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Cortisol II assay makes use of a competition test principle using a monoclonal antibody which is specifically directed against cortisol. Endogenous cortisol which has been liberated from binding proteins with danazol competes with exogenous cortisol derivative in the test which has been labeled with ruthenium complex for the binding sites on the biotinylated antibody.
Results are determined via a calibration curve which is instrument specifically generated by 2point calibration and a master curve provided via reagent barcode.
The reagent working solutions include:
- rackpack (kit placed on instrument) .
- Streptavidin coated microparticles, ş
- Reagent 1 (Anti-cortisol-Ab~biotin) and ş
- Reagent 2 (Cortisol-peptide~Ru(bpy)2+3). ş
The Cortisol II CalSet is a lyophilized human serum with added cortisol in two concentration ranges.
The CalSet includes:
- Cal 1 (approximately 12.5 nmol/L cortisol in a human serum matrix) .
- Cal 2 (approximately 1000 nmol/L cortisol in a human serum matrix) .
The provided document describes the Elecsys Cortisol II immunoassay and its associated calibrator, Cortisol II CalSet. It details various non-clinical performance evaluations and one clinical performance evaluation.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a dedicated table for each technical performance study. Instead, it presents the results of these studies and implies that these results demonstrate the device's performance is acceptable and supports substantial equivalence to the predicate device. For analytical specificity and method comparison, the document includes tables comparing some key characteristics with the predicate device. For other studies like precision, linearity, and sensitivity, it reports the performance without directly listing a pre-defined acceptance criterion.
However, I can extract the reported performance directly from the document for key metrics.
| Performance Characteristic | Predicate Device (Elecsys Cortisol - K070788) Performance | Candidate Device (Elecsys Cortisol II) Reported Performance |
|---|---|---|
| Measuring Range | 0.5 – 1750 nmol/L | 3.0 – 1750 nmol/L |
| Precision (Within-run) | Sample Mean (nmol/L) SD %CV | |
| HS 1: 208, 2.76, 1.3% | ||
| HS 2: 561, 7.40, 1.3% | ||
| HS 3: 1268, 14.0, 1.1% | ||
| PCU* 1: 363, 5.08, 1.4% | ||
| PCU* 2: 865, 8.54, 1.0% | Sample Mean (nmol/L) SD CV | |
| HS 1: 3.09, 0.219, 7.1% | ||
| HS 2: 35.8, 0.718, 2.0% | ||
| HS 3: 283, 7.29, 2.6% | ||
| HS 4: 548, 10.4, 1.9% | ||
| HS 5: 1592, 29.3, 1.8% | ||
| PCU* 1: 308, 4.33, 1.4% | ||
| PCU* 2: 719, 10.4, 1.4% | ||
| Precision (Total/Intermediate) | Sample Mean (nmol/L) SD %CV | |
| HS 1: 208, 3.29, 1.6% | ||
| HS 2: 561, 8.36, 1.5% | ||
| HS 3: 1268, 19.9, 1.6% | ||
| PCU* 1: 363, 5.67, 1.6% | ||
| PCU* 2: 865, 12.5, 1.4% | Sample Mean (nmol/L) SD CV | |
| HS 1: 3.09, 0.392, 12.7% | ||
| HS 2: 35.8, 1.36, 3.8% | ||
| HS 3: 283, 9.39, 3.3% | ||
| HS 4: 548, 17.4, 3.2% | ||
| HS 5: 1592, 42.7, 2.7% | ||
| PCU* 1: 308, 8.35, 2.7% | ||
| PCU* 2: 719, 18.0, 2.5% | ||
| Analytical Sensitivity | Limit of Detection = |
§ 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.