(145 days)
Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and urine. 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 the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
The ELECSYS® Cortisol Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code.
The information provided describes the Elecsys® Cortisol Assay and its substantial equivalence to a predicate device (Bayer Diagnostics ACS:180 Cortisol Assay). It focuses on comparing the new device's performance characteristics to the predicate device to demonstrate substantial equivalence, rather than detailing a specific study proving the device meets acceptance criteria with predefined thresholds. Therefore, some of the requested information cannot be fully extracted as it pertains to a typical clinical validation study with explicitly stated acceptance criteria and a detailed study design.
Here's the breakdown of what can be extracted and what is not available in the provided text:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" through specific numerical thresholds for each performance characteristic. Instead, it demonstrates performance by comparing the new device's data directly to that of the predicate device, implying that performance comparable to the legally marketed predicate device is the de facto acceptance criteria for substantial equivalence.
| Feature | Acceptance Criteria (Implied: Comparable to Predicate) | New Device (ELECSYS Cortisol) Reported Performance | Predicate Device (Bayer ACS:180 Cortisol) Reported Performance |
|---|---|---|---|
| Intra-assay precision (%CV) (Urine) | Comparable to Predicate's Intra-assay precision | • 2.2% at 22.3 µg/dl | |
| • 2.3% at 33.2 µg/dl | |||
| • 2.9% at 41.9 µg/dl | |||
| • 2.3% at 61.0 µg/dl | • 5.7% at 3.04 µg/dl | ||
| • 5.1% at 5.43 µg/dl | |||
| • 4.5% at 14.90 µg/dl | |||
| • 6.4% at 18.98 µg/dl | |||
| • 7.0% at 31.79 µg/dl | |||
| • 7.5% at 38.67 µg/dl | |||
| Interassay precision (%CV) (Urine) | N/A (Predicate data not fully provided) | • 2.5% at 23.2 µg/dl | |
| • 3.2% at 33.4 µg/dl | |||
| • 2.5% at 42.1 µg/dl | |||
| • 1.8% at 58.9 µg/dl | |||
| Control: 4.7% at 2.82 µg/dl | N/A | ||
| Total precision (%CV) | Comparable to Predicate's Total precision | N/A | • 9.1% at 3.04 µg/dl |
| • 8.0% at 5.43 µg/dl | |||
| • 6.4% at 14.90 µg/dl | |||
| • 8.2% at 18.98 µg/dl | |||
| • 9.2% at 31.79 µg/dl | |||
| • 9.7% at 38.67 µg/dl | |||
| Functional sensitivity | Comparable or better than Predicate's functional sensitivity |
§ 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.