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510(k) Data Aggregation
(52 days)
ARCHITECT CORTISOL ASSAY
ARCHITECT® Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders.
The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cortisol in human serum, plasma or urine.
The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma or urine using CMIA technology with flexible assay protocols, referred to as Chemiflex®.
Here's a breakdown of the acceptance criteria and study details for the ARCHITECT Cortisol assay:
1. Table of Acceptance Criteria and Reported Device Performance:
Test Category | Acceptance Criteria | Reported Device Performance |
---|---|---|
Linearity | Target +/- 20% Deviation (at 0% dilution for both serum pools) | - 65 ug/dL Serum Pool: %DLP ranged from -8% to 4% for diluted samples. At the 0% dilution, the difference was-1.6 ug/dL, compared to the target value of N/A, which is acceptable relative to the ±20% deviation criteria. - 8 ug/dL Serum Pool: %DLP ranged from -12% to 3% for diluted samples. At the 0% dilution, the difference was-0.2 ug/dL, which is acceptable relative to the ±20% deviation criteria. |
Accuracy (Recovery) | Serum: Target Recovery 100 ± 15% Urine: Target Recovery 100 ± 20% | - Serum: % Recovery ranged from 86.1% to 98.5%. All values are within the acceptance criteria of 100 ± 15% (i.e., 85% to 115%). - Urine: % Recovery ranged from 84.6% to 100.9%. All values are within the acceptance criteria of 100 ± 20% (i.e., 80% to 120%). |
Sensitivity (LoD) | Assay claim of LoD = 0.8 ug/dL is supported by data. | - ARCHITECT i2000 LoD = 0.401 ug/dL - ARCHITECT i2000SR LoD = 0.255 ug/dL - Functional sensitivity (20% CV): Serum = 0.8 ug/dL, Urine = 1 ug/dL. All reported LoD values are less than or equal to the claimed 0.8 ug/dL for serum, and urine is close at 1 ug/dL, thus supporting the claim. |
Method Comparison | The results of the Method comparison study met the design goals and acceptance criteria. (Specific numerical criteria not provided in the summary) | The summary states that "The results of the Method comparison study met the design goals and acceptance criteria." No specific numerical values for agreement or bias are provided. |
Precision | Serum: |
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