(189 days)
The ADVIA Centaur® Cortisol (COR) Assay is for in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur XP system. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
The ADVIA Centaur Cortisol assay is a competitive immunoassay using direct chemiluminescent technology. Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve with the reagent bar code. The ADVIA Centaur Cortisol Assay is intended for use on the ADVIA Centaur Family of analyzers. The ADVIA Centaur Calibrator E is a set of 2 level calibrators for the assay. Siemens recommends the use of commercially available quality control materials with at least two levels (low and high).
Here's a breakdown of the acceptance criteria and the study details for the ADVIA Centaur® Cortisol (COR) Assay, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Acceptance Criteria (Implicit from satisfactory results) | Reported Device Performance (Summary) | Comment |
|---|---|---|---|---|
| Precision | CLSI EP05-A2 protocol (20-day study, 2 reps/run, 2 runs/day) | Within-Lab %CV should be acceptable | Serum: 4.4% - 6.0% (Controls), 4.9% - 5.3% (Samples) | |
| Direct Urine: 6.8% - 9.1% | ||||
| Extracted Urine: 6.8% - 9.2% | Performance appears to be within generally accepted clinical chemistry precision standards, demonstrating good reproducibility. | |||
| Linearity/Assay Range | Linearity across the measuring range (EP06-A) | % Recovery should be acceptable, high r² (correlation) | Serum: Y=1.057x - 0.051, r²=0.9991, % Recovery 96.0-109.3% | |
| Direct Urine: Y=1.011x + 0.090, r²=0.9975, % Recovery 94.7-119.6% | ||||
| Extracted Urine: Y=0.914x + 0.017, r²=0.9997, % Recovery 82.7-100.9% | Strong linearity demonstrated with high r² values close to 1, indicating a good proportional relationship between expected and observed values over the claimed analytical range. The urine recoveries showed a slightly wider range but were still deemed acceptable. | |||
| Analytical Detection Limits | LoB, LoD, LoQ (EP17-A2) | Values should be below claimed measuring range | LoB: Serum 0.06 µg/dL, Direct Urine 0.19 µg/dL, Extracted Urine 0.18 µg/dL | |
| LoD: Serum 0.14 µg/dL, Direct Urine 0.45 µg/dL, Extracted Urine 0.44 µg/dL | ||||
| LoQ: Serum 0.31 µg/dL, Direct Urine 0.48 µg/dL, Extracted Urine 0.44 µg/dL | The determined detection limits are well below the lower end of the claimed measuring range (0.50 µg/dL), supporting the device's ability to accurately measure low concentrations. | |||
| Analytical Specificity (Interference) | Endogenous substances (EP07-A2) | % Interference ≤ 10% | All tested endogenous substances (Hemoglobin, Triglycerides, Bilirubin, Protein, NaCl, Urea, Creatinine, Glucose, Boric Acid) showed % Interference within -5% to 5%. | The device demonstrates good resistance to interference from common endogenous substances in both serum and urine, ensuring reliable results in various patient samples. |
| Analytical Specificity (Cross-reactivity) | Potential cross-reactant compounds | Low cross-reactivity with structurally similar compounds | Most compounds showed low cross-reactivity ( |
§ 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.