(134 days)
The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.
The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.
Here's a breakdown of the acceptance criteria and study information for the Vital Scientific APTT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Vital Scientific APTT Performance |
|---|---|---|
| Correlation with Predicate Device (APTT-LS on MLA 900C) | "acceptable correlation" (implied by K891337) | Correlation coefficient = 0.938, Slope = 0.727, Intercept = 6.96. The document states this indicates "acceptable correlation." |
| Correlation with Predicate Device (APTT-LS on ACL-100) | "acceptable correlation" (implied by K881367) | Correlation coefficient = 0.930, Slope = 0.952, Intercept = 3.76. The document states this indicates "acceptable correlation." |
| Within-run Precision (%CV) | " |
§ 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).