(117 days)
Sigma Diagnostics ALEXIN™ LS is a device used for primary screening for coagulation Shina Diagnest of evaluation of the effect of therapy on procoagulant disorders, and as able mail.com factor deficiencies of the intrinsic coagulation pathway.
Sigma Diagnostics ALEXIN™ LS contains purified rabbit brain and sov phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma. This reagent has increased sensitivity to lupus anticoagulants.
The provided document describes the safety and effectiveness study for the Sigma Diagnostics ALEXIN™ LS device, demonstrating its substantial equivalence to the Dade Actin-FSL device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this device appear to be a strong correlation and agreement with a legally marketed predicate device (Dade Actin-FSL). The precision data also represents performance within expected ranges for such assays.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (ALEXIN™ LS vs. Dade Actin-FSL) |
|---|---|---|
| Correlation Coefficient | High correlation (e.g., > 0.90) between ALEXIN™ LS and predicate device | Optical Mode: 0.97 |
| Mechanical Mode: 0.98 | ||
| KC 4A Analyzer: 0.95 | ||
| Regression Equation (Slope/Intercept) | Close agreement (slope near 1, intercept near 0) | Optical Mode: y = 0.91x + 0.10 |
| Mechanical Mode: y = 0.92x + 0.08 | ||
| KC 4A Analyzer: y = 0.86x + 0.15 | ||
| Precision (Within-Run CV%) | Low variability (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).