(117 days)
Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
Sigma Diagnostics ALEXIN 14 HS contains purified rabbit brain and soy phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma.
Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway. The study aimed to demonstrate its substantial equivalence to Dade Actin-FS.
1. Table of acceptance criteria and reported device performance:
The document doesn't explicitly state "acceptance criteria" in a numerical sense, but rather demonstrates substantial equivalence through correlation and regression with a predicate device, and provides precision data. For the purpose of this analysis, we will infer the acceptance criteria from the reported performance, implying that the achieved correlation and precision were considered acceptable for substantial equivalence.
| Metric | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (ALEXIN™ HS) |
|---|---|---|
| Correlation with Dade Actin-FS (Optical Mode) | High correlation (e.g., > 0.95 or similar to predicate) | 0.97 |
| Correlation with Dade Actin-FS (Mechanical Mode) | High correlation (e.g., > 0.95 or similar to predicate) | 0.97 |
| Correlation on KC 4A analyzer | High correlation (e.g., > 0.95 or similar to predicate) | 0.96 |
| Regression Equation (Optical Mode) | Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0) | y = 0.81 x + 0.31 |
| Regression Equation (Mechanical Mode) | Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0) | y = 0.84 x + 0.28 |
| Regression Equation (KC 4A analyzer) | Regression line close to y = x (i.e., slope ≈ 1, intercept ≈ 0) | y = 0.94 x + 0.08 |
| Within-Run Precision (Control I CV%) | Low variability (e.g., typically |
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).